Food for human consumption: Food labeling— Soluble dietary fiber and coronary heart disease; health claims,

[Federal Register: December 23, 2005 (Volume 70, Number 246)]

[Rules and Regulations]

[Page 76150-76162]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23de05-6]

[[Page 76150]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2004P-0512]

Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the regulation authorizing a health claim on the relationship between oat beta-glucan soluble fiber and reduced risk of coronary heart disease (CHD). The amendment adds barley as an additional eligible source of beta-glucan soluble fiber. We (FDA) are taking this action in response to a petition that the National Barley Foods Council submitted. We have concluded, based on the totality of publicly available scientific evidence that, in addition to certain oat products, whole grain barley and certain dry milled barley grain products are appropriate sources of beta-glucan soluble fiber for the health claim.

DATES: This interim final rule is effective December 23, 2005. Submit written or electronic comments by March 8, 2006. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR 101.81(c)(2)(ii)(A)(5) as of December 23, 2005.

ADDRESSES: You may submit comments, identified by the Docket Number 2004P-0512 , by any of the following methods: Electronic Submissions

Submit electronic comments in the following ways:

Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Agency Web site: http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site. Written Submissions

Submit written submissions in the following ways:

FAX: 301-827-6870.

Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the Electronic Submissions portion of this paragraph.

Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm , including any personal information provided. For

additional information on submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm

and insert the docket number(s), found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD, 20740-3835, telephone 301- 436-1450.

SUPPLEMENTARY INFORMATION:

  1. Background

    1. The Nutrition Labeling and Education Act of 1990

      The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. One aspect of the 1990 amendments was that they clarified FDA's authority to regulate health claims on food labels and in food labeling. We issued several new regulations in 1993 that implemented the health claim provisions of the 1990 amendments. Among these were Sec. 101.14 (21 CFR 101.14), Health Claims: General Requirements (58 FR 2478, January 6, 1993), which sets out the rules for the authorization and use of health claims, and Sec. 101.70 (21 CFR 101.70), Petitions for Health Claims (58 FR 2478, January 6, 1993), which sets out a process for petitioning the agency to authorize health claims about substance-disease relationships, and sets out the types of information that any such petition must include. Each of these regulations became effective on May 8, 1993.

      When implementing the 1990 amendments, we also conducted a review of evidence for a relationship between dietary fiber and cardiovascular disease (CVD). Based on this review, we concluded that the available scientific evidence did not justify authorization of a health claim relating dietary fiber to reduced risk of CVD (58 FR 2552, January 6, 1993). However, we did conclude there was significant scientific agreement that the totality of publicly available scientific evidence supported an association between types of foods that are low in saturated fat and cholesterol and that naturally are good sources of soluble dietary fiber (i.e., fruits, vegetables, and grain products) and reduced risk of CHD\1\. We therefore authorized a health claim about the relationship between diets low in saturated fat and cholesterol and high in vegetables, fruit, and grain products that contain soluble fiber and a reduced risk of CHD (21 CFR 101.77; 58 FR 2552 at 2572). In the preamble to the 1993 dietary fiber and CVD final rule, FDA commented that if a manufacturer could document with appropriate evidence that consumption of the type of soluble fiber in a particular food has the effect of lowering blood low density lipoprotein (LDL) cholesterol, and has no adverse effects on other heart disease risk factors (e.g., high density lipoprotein (HDL) cholesterol), it should petition for authorization of a health claim specific for that particular dietary fiber-containing food (58 FR 2552 at 2567).

      \1\ CVD means diseases of the heart and circulatory system. Coronary heart disease, one form of cardiovascular disease, refers to diseases of the heart muscle and supporting blood vessels.

    2. Soluble Fiber From Certain Foods and Coronary Heart Disease Health Claim (Sec. 101.81 (21 CFR 101.81))

      In 1995, FDA received a petition for a health claim on the relationship between oat bran and rolled oats and reduced risk of CHD. FDA concluded there was significant scientific agreement that the totality of publicly available scientific evidence supported the relationship between consumption of whole oat products and reduced risk of CHD. FDA further concluded that the type of soluble fiber found in whole oats, i.e., beta-glucan soluble fiber, is the component primarily responsible for the hypocholesterolemic effects associated with consumption of whole oat foods as part of a diet that is low in saturated fat

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      and cholesterol (62 FR 3584 at 3597-3598, January 23, 1997). As such, the final rule authorized a health claim relating the consumption of beta-glucan soluble fiber in whole oat foods, as part of a diet low in saturated fat and cholesterol, and reduced risk of CHD (the oat beta- glucan health claim). The source of beta-glucan soluble fiber in foods bearing this health claim had to be one of three eligible whole oat products; i.e., oat bran, rolled oats, or whole oat flour (see Sec. 101.81(c)(2)(ii)(A)). In 2002, FDA amended this health claim regulation to add oatrim as a fourth eligible source of beta-glucan soluble fiber (67 FR 61733, October 2, 2002). Oatrim is the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour.

      In the 1997 oat beta-glucan health claim final rule, we anticipated the likelihood that other sources and types of soluble fibers will also affect blood lipid levels, and thus, may reduce heart disease risk (62 FR 3584 at 3587). At that time, FDA considered structuring the final rule as an umbrella regulation authorizing the use of a claim for ``soluble fiber from certain foods'' and risk of CHD. Such action would have allowed flexibility in expanding the claim to other specific food sources of soluble fiber when consumption of those foods has been demonstrated to help reduce the risk of heart disease. However, the agency concluded that it was premature to do so inasmuch as FDA had not reviewed the totality of publicly available evidence on other, non- whole oat sources of soluble fiber (62 FR 3584 at 3588). In 1998, in response to a health claim petition, FDA concluded that soluble fiber of psyllium seed husk, similar to beta-glucan soluble fiber from whole oats, may reduce the risk of CHD by lowering blood cholesterol levels (63 FR 8103, February 18, 1998). In that final rule, FDA broadened Sec. 101.81 to include soluble fiber from psyllium seed husk, and also modified the heading in Sec. 101.81 from, ``* * * Soluble fiber from whole oats and risk of coronary heart disease'' to ``* * *Soluble fiber from certain foods and risk of coronary heart disease (CHD).''

  2. Petition and Grounds

    1. The Petition

      The National Barley Foods Council (petitioner), submitted a health claim petition to FDA on August 3, 2004, under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)). The petition requested that the agency amend the ``Soluble fiber from certain foods and coronary heart disease health claim'' at Sec. 101.81 to include barley and barley products as an additional source of beta-glucan soluble fiber eligible for the health claim (Ref. 1). On November 10, 2004, we notified the petitioner that we had completed our initial review of the petition and that the petition had been filed for further action in accordance with section 403(r)(4) of the act. If the agency does not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing for further action, the petition is deemed to be denied unless an extension is mutually agreed upon by the agency and the petitioner (section 403(r)(4)(A)(i) of the act and Sec. 101.70(j)(3)(iii)). On February 4, 2005, FDA and the petitioner mutually agreed to extend the deadline to publish the agency's decision on the petition until August 9, 2005. On August 3, 2005, FDA and the petitioner agreed to further extend the deadline to December 31, 2005. The petitioner requested that FDA issue an interim final rule by which labeling of barley-containing foods could bear the health claim prior to publication of a final rule.

    2. Nature of the Substance

      The petitioner requests that Sec. 101.81 be amended to include barley in addition to oats as a source of beta-glucan soluble fiber associated with reducing the risk of CHD. The petitioner further requests that whole grain barley (dehulled or hulless), and certain dry milled barley products, i.e., pearl, flakes, grits, meal, flour, beta- glucan enriched meal fractions, and bran, be determined as eligible barley sources of beta-glucan soluble fiber.

      The substance which is the subject of the existing oat beta-glucan health claim is beta-glucan soluble fiber from oat sources listed in Sec. 101.81(c)(2)(ii)(A). The requested amendment will expand the substance of the claim to include both oat and barley sources of beta- glucan soluble fiber. From an analytical perspective, beta-glucan soluble fiber from barley is the same substance as beta-glucan soluble fiber from oat sources. The method now specified in Sec. 101.81(c)(2)(ii)(A) for the measurement of beta-glucan soluble fiber from oat sources, AOAC Official Method 992.28, is a method designated by AOAC INTERNATIONAL to be used for both oat and barley fractions and it is the same analytical method identified by the petition for measurement of beta-glucan soluble fiber from barley sources.

      The petition characterizes the barley sources of beta-glucan soluble fiber as dehulled or hulless whole grain barley and barley products produced from dehulled or hulless clean, sound barley grain by standard dry milling processes, which may include steaming or tempering, and that provide at least 4 percent (dry weight basis (dwb)) of beta-glucan soluble fiber and total dietary fiber content of at least 8 percent (dwb) (flour, grits, flakes, and meal), or at least 5.5 percent (dwb) of beta-glucan soluble fiber and at least 15 percent (dwb) total dietary fiber (bran and beta-glucan enriched barley fractions). For whole grain (dehulled and hulless) barley, the petition specified the minimum beta-glucan soluble fiber content as 4 percent (dwb) and the minimum total dietary fiber content as 10 percent (dwb).

      Most barley varieties have a tough fibrous adherent hull covering the grain which must be removed for the grain to be edible. There are also hulless barley varieties in which, similar to wheat, the hull falls away during harvesting and the grain can be processed directly into food products without dehulling. The petition thus has specified the eligible sources of the barley beta-glucan soluble fiber to include both dehulled and hulless whole barley grain.

      In addition to dehulled or hulless whole barley grain, the petition has specified that dry milled barley products that are eligible sources of the beta-glucan soluble fiber be produced from dehulled or hulless barley grain by standard dry milling processes. The petition includes dry milled barley products only and does not include beta-glucan extracts produced through ``wet milling'' processes. Wet milling processes used to extract or concentrate the beta-glucan soluble fiber component of barley are likely to alter physiochemical properties of fiber and other components of the grain. All but two of the dry milled barley products specified in the petition have been formally defined by the American Association of Cereal Chemists (AACC) in a ``Barley Glossary'' which is published in AACC Approved Methods (Ref. 2). Two additional dry milled barley products, which are not defined in the AACC Barley Glossary, i.e., barley meal and beta-glucan enriched barley fractions, are included in the petition as beta-glucan soluble fiber sources. The petition characterizes barley meal as differing from barley flour only in that it is unsifted and thus has a higher portion of bran and germ present than sifted barley flour. The petition has defined ``beta-glucan enriched barley fractions'' as fractions of dry milled barley that are enriched in endosperm cell walls by either mechanical sifting or air classification and that provide at least 5.5 percent (dwb) of beta-glucan soluble fiber and a total dietary fiber content of at least 15 percent (dwb). The

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      beta-glucan content of barley endosperm cell walls is greater than that of barley endosperm cell contents. During milling, endosperm cell walls break up into larger particles than do endosperm cell contents. Sieving or air classification milling steps can be used to separate milled barley flour or meal by particle size to produce endosperm cell wall- enriched fractions. Since barley endosperm cells walls have a greater beta-glucan content than do barley endosperm cell contents, these endosperm cell wall-enriched barley fractions have a greater beta- glucan content than of the starting flour or meal. For simplicity, in this document we will be referring to endosperm cell wall-enriched barley fractions as ``sieved barley meal.''

      The petition specifies that the dry milled barley products which are the subject of this petition, with the exception of barley bran and sieved barley meal, have a minimum beta-glucan soluble fiber content of at least 4 percent (dwb), and a minimum total dietary fiber content of at least 8 percent (dwb). The petition specifies that eligible barley bran and sieved barley meal have a minimum beta glucan soluble fiber and total dietary fiber content of 5.5 percent (dwb) and 15 percent (dwb) respectively. The petition specifies that eligible whole grain barley (dehulled and hulless) have a minimum beta glucan soluble fiber and total dietary fiber content of 4 percent dwb and 10 percent dwb respectively. The petitioner selected the minimum beta-glucan soluble fiber and total dietary fiber content specifications for the whole grain barley and dry milled barley products that are eligible sources of beta-glucan soluble fiber to be inclusive of most all commercially available dry milled barley products, while excluding barley products such as barley brewers grain in which the soluble fiber has been depleted.

    3. Review of Preliminary Requirements for a Health Claim

      1. The Substance Is Associated With a Disease for Which the U.S. Population Is at Risk

      CHD continues to be a disease that has a large impact on mortality and morbidity in the general adult U.S. population. As explained in the existing oat beta-glucan health claim (Sec. 101.81(b)), FDA recognizes the CHD risk reduction benefit of certain foods that are sources of soluble dietary fiber resulting from effects on lowering blood total and LDL-cholesterol. Although age-adjusted CHD mortality rates in the United States had been steadily decreasing since approximately 1960, recent evidence has suggested that the decline in CHD mortality has slowed (Ref. 3). Heart disease has been recognized as the leading cause of death in the United States for at least the last 50 years (Ref. 3). Based on these facts, FDA concludes that, as required in Sec. 101.14(b)(1), CHD is a disease for which the U.S. population is at risk. 2. The Substance Is a Food

      The substance which is the subject of the existing oat beta-glucan health claim is beta-glucan soluble fiber from specified oat sources, i.e., oat bran, rolled oats, whole oat flour, and oatrim (Sec. 101.81(c)(2)(ii)(A)). The petitioner requests an amendment to extend the eligible sources of beta-glucan soluble fiber to include those from whole grain barley and certain dry milled barley products. Barley grain is a commonly consumed human food and beta-glucan soluble fiber is a nutrient component of this food, thus the beta-glucan soluble fiber from whole grain barley and dry milled barley products that include bran, flakes, grits, pearl, flour, meal, and sieved barley meal is a ``substance'' as defined by Sec. 101.14(a)(2). Health claim general requirements provide that where a substance is to be consumed at ``other than decreased dietary levels'' the substance must contribute taste, aroma, nutritive value, or any other technical effect as listed in 21 CFR 170.3(o), and must retain that attribute when consumed at levels necessary to justify the claim (Sec. 101.14(b)(3)(i)). Whole grain barley and dry milled barley products are consumed by humans for their nutritive value, and retain that attribute when consumed at levels necessary to justify the claim. Thus the agency concludes that the requirement of Sec. 101.14(b)(3)(i) is satisfied. 3. The Substance Is Safe and Lawful

      Section 101.14(b)(3)(ii) requires that the substance be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify a claim has been demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the act. The petition states that dry milled barley grain is a human food of natural biological origin that has been widely consumed in the United States for its nutrient properties prior to January 1, 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists. The petitioner's description of the use of dry milled barley grain as a food ingredient and the use of whole grain barley, as sources of barley beta-glucan soluble fiber, are consistent with FDA's definition of food ingredients ordinarily regarded as ``generally recognized as safe'' (GRAS) (21 CFR 170.30(d)). FDA is satisfied that the petitioner has demonstrated the use of barley beta-glucan soluble fiber, from whole grain barley and dry milled barley grain product sources that are included in this rule, is safe and lawful under the applicable food safety provision of the act.

  3. Review of Scientific Evidence of the Substance-Disease Relationship

    1. Basis for Evaluating the Relationship Between Barley and CHD

      FDA has identified the following endpoints to use in identifying CHD risk reduction for purposes of a health claim evaluation: Coronary events (myocardial infarction, ischemia), cardiovascular death, atherosclerosis, high blood pressure, elevated serum total cholesterol, and elevated serum LDL-cholesterol. FDA considers high blood pressure, elevated serum total cholesterol, and elevated serum LDL-cholesterol levels as surrogate endpoints for CHD (Ref. 4). FDA considers low HDL- cholesterol levels a risk factor for CHD (National Institutes of Health Consensus Conference, 1993). Elevated levels of serum total and LDL cholesterol, a prerequisite for atherosclerotic disease, is a major cause of CHD (Ref. 4). To evaluate the potential effects of beta-glucan soluble fiber from whole grain barley and dry milled barley products on CHD risk, FDA focused on serum total and LDL cholesterol levels to evaluate the relationship between barley beta-glucan and CHD risk. This focus is consistent with existing Sec. 101.81, in which FDA concluded that there was significant scientific agreement that the relationship between consumption of whole grain oats and CHD risk is mediated primarily by the effect of dietary beta-glucan soluble fiber on serum lipids.

      FDA previously concluded that there is significant scientific agreement regarding the relationship between consumption of soluble fiber-containing whole oat foods and reduced risk of CHD (62 FR 3584 at 3598). FDA concluded that the type of soluble fiber found in whole oat foods, i.e., beta-glucan soluble fiber, is primarily responsible for the observed association between consumption of whole oat foods and the lowering of blood cholesterol. As such, to evaluate the evidence supporting the petitioned

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      request to extend the beta-glucan soluble fiber from whole oat health claim to include beta-glucan soluble fiber from whole grain barley and dry milled barley products, FDA focused on evidence from human clinical studies of the effects of consuming beta-glucan soluble fiber from whole grain barley and dry milled barley products on blood lipids.

    2. Review of Scientific Evidence of the Substance-Disease Relationship

      A health claim characterizes the relationship between a substance and a disease or health-related condition (21 CFR 101.14(a)(1)). The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup, is at risk (Sec. 101.14(b)(1)). Health claims characterize the relationship between the substance and a reduction in risk of contracting a particular disease.\2\

      \2\ See Whitaker v. Thompson, 353 F.3d 947, 950-51 (D.C. Cir.) (upholding FDA's interpretation of what constitutes a health claim), cert. denied, 125 S.Ct. 310 (2004).

      FDA's review of the evidence to support the petitioned amendment of the oat beta-glucan health claim was conducted consistent with FDA published guidance on significant scientific agreement in the review of health claims (Ref. 5) and focused on evidence from intervention studies. 1. Assessment of Intervention Studies

      This petition identified reports of 11 human clinical studies with data on barley consumption and serum lipids (Refs. 6 to 16). We excluded six of these reports from our review because no scientific conclusions relative to effects of barley beta-glucan soluble fiber on CHD risk could be drawn from them. One of these excluded reports (Ref. 6) was available only as an abstract and therefore did not provide sufficient information about the study for FDA to determine critical elements, such as the study population characteristics and the composition of the products used. In addition, the lack of a detailed study description prevents FDA from determining whether the study is flawed in critical elements such as design, conduct, and data analysis. FDA must be able to review the critical elements of a study to determine whether any scientific conclusions relevant to the health claim can be drawn from it. These problems are not limited to abstracts, but include other similar publications, such as meta- analyses\3\ and review articles,\4\ book chapters, letters to the editor, and committee reports.

      \3\ A meta-analysis is the process of systematically combining and evaluating the results of clinical trials that have been completed or terminated.

      \4\ Review articles summarize the findings of individual studies.

      A second excluded report, Lupton et al., 1994 (Ref. 7), tested potential cholesterol-lowering effects of spent brewer's grain barley and of barley oil, neither of which contains beta-glucan soluble fiber. Because this report did not provide information about the substance that is the subject of the health claim, it was excluded from further review. Another excluded report, Keogh et al., 2003 (Ref. 8), tested potential cholesterol-lowering effects of a beta-glucan concentrate product extracted from barley bran. The whole grain barley and dry milled barley products which are the sources of beta-glucan soluble fiber in the petition do not include wet milled barley products such as the beta-glucan concentrate used in Keogh et al., 2003. Beta-glucan extraction processes (e.g., hot water or alcohol washes, and extreme pH conditions), unlike dry milling processes, are likely to alter physiochemical properties of soluble fiber and other components of grain and will alter the relative proportions of beta-glucan soluble fiber and other components of the grain. The composition of wet milled barley beta-glucan products may be substantially different from that of dry milled barley products and thus the results of Keogh et al., 2003 do not assist our evaluation of evidence supporting a health claim for dry milled barley products. The three other excluded reports (Refs. 9, 10, and 11) did not contain enough information to estimate the barley beta-glucan soluble fiber in the test diets. Without knowing the amount of barley beta-glucan soluble fiber added to these studies' diets, FDA was unable to draw any conclusions as to the effect of barley beta- glucan soluble fiber on CHD risk from this evidence. The remaining 5 of the 11 reports of human clinical studies (Refs. 12 to 16) were of a sufficient quality for us to consider in our review of the evidence supporting the relationship between reduced risk of CHD and consumption of beta-glucan soluble fiber from whole grain barley and dry milled barley products included as sources of beta-glucan soluble fiber in this petition.

      The study reported in Behall et al., 2004a (Ref. 12) investigated the effects of dry milled barley products (barley flour, barley flakes, and pearled barley) incorporated into a controlled whole-grain diet on blood lipids of mildly hypercholesterolemic men. The study included 18 mildly hypercholesterolemic adult males (mean age 46 years; mean baseline total cholesterol 238 milligrams/deciliter (mg/dL); mean baseline LDL-cholesterol 155 mg/dL). The test diet was a Step I diet (total fat 31 percent of energy, saturated fat 7.6 percent of energy, total dietary fiber 27 grams (g)/day) that included whole grain test foods (pancakes, spice cake, no-bake cookies, hot cereal, toasted flakes, steamed pilaf, and muffins). The test personnel prepared three versions of the whole grain test diet differing in levels of dry milled barley products. One version of the test diet, made with whole wheat flour, wheat flakes, and brown rice, but no barley, contained only trace amounts of beta-glucan soluble fiber. Another version of the test diet made with barley flour, barley flakes, and pearled barley replacing the wheat and rice in test foods, provided 6 g barley soluble fiber per day. The third version of the test diet was made with half whole wheat/brown rice and half barley to provide 3 g barley soluble fiber per day. The three whole grain test diets were designed to provide approximately the same amount of total dietary fiber per day, and vary only in the amount of barley beta-glucan soluble fiber. Following a 2-week run-in period consuming the test diet without barley to allow subjects to adjust to the dietary fiber level, the study administered each the three test diets (0, 3, or 6 g per day barley soluble fiber) to each participant in random order over three consecutive 5-week periods. In comparison to the 0 g per day barley soluble fiber diet period, there was a statistically significant (p

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