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The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels

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ClinicalTrials.gov Identifier: NCT03450395
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE March 1, 2018
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE January 28, 2018
Actual Primary Completion Date August 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
Fecal bacterial population(s) [ Time Frame: Baseline and Week 6 ]
Increase/decrease in desirable fecal bacterial groups (specifically, but not limited to, Bifidobacterium spp. and Lactobacillus/Enterococcus spp.).
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
changes in fecal bacterial population(s) [ Time Frame: 6 weeks after daily consumption at breakfast ]
changes in fecal bacterial population(s) elicited by daily consumption of 40g of Oats at breakfast with that after daily consumption of 40g of Cream of Rice at breakfast over 6 weeks.
Change History Complete list of historical versions of study NCT03450395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • Fecal Bile Salt Hydrolase [ Time Frame: Change from baseline and Week 6 ]
    (ng-μg/g)
  • Fecal bile acid profile [ Time Frame: Change from baseline Week 6 ]
    (ng-μg/g)
  • Fecal bacterial diversity change [ Time Frame: Change from baseline to Week 6 ]
    Increase/decrease in desirable fecal bacterial groups (specifically, but not limited to, Bifidobacterium spp. and Lactobacillus/Enterococcus spp.). Increase would be better.
  • Serum FGF-19 [ Time Frame: Change from baseline to Week 6 ]
    Fibroblast growth factor (pg/ml)
  • Plasma total Cholesterol [ Time Frame: Change from baseline to Week 6 ]
    mmol/L, lower would be better
  • Change in Plasma HDL Cholesterol [ Time Frame: Change from baseline to Week 6 ]
    mmol/L, higher would be better
  • Change in Plasma LDL Cholesterol [ Time Frame: Change from baseline to Week 6 ]
    mmol/L, lower would be better
  • Change in Plasma Triglycerides [ Time Frame: Change from baseline to Week 6 ]
    mmol/L lower would be better
  • Change in Plasma Propionate (propanoic acid) [ Time Frame: Change from baseline to Week 6 ]
    (µM)
  • Stool frequency [ Time Frame: Changes from baseline through 6 weeks ]
    Bowel movements recorded in daily diary
  • Change in stool consistency [ Time Frame: Changes from baseline through 6 weeks ]
    Bristol Stool Scale, for each bowel movement, select closest appearance from chart. 7 types ranging from watery to hard lumps
  • Change in gastrointestinal symptoms [ Time Frame: Changes from baseline through 6 weeks ]
    Pain, discomfort, bloating & flatulence recorded using subjective GI symptom ranking questionnaire 6 point scale from none to severe for 4 measures: pain, discomfort, bloating, flatulence. No changes would be better.
  • Quality of Life Score [ Time Frame: Changes from baseline through 6 weeks ]
    SF-36 questionnaire (SF= Short form)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • Fecal Bile Salt Hydrolase [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • fecal bile acid profile change [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Fecal bacterial diversity change [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in serum FGF-19 [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in plasma total Cholesterol [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in Plasma HDL Cholesterol [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in Plasma LDL Cholesterol [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in Plasma Triglycerides [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in Plasma Propionate [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • stool frequency (daily bowel movements) [ Time Frame: 6 weeks after daily consumption at breakfast ]
  • Change in stool consistency based on 'Bristol' Stool Scale [ Time Frame: 6 weeks after daily consumption at breakfast ]
    using Bristol Stool Scale
  • Change in gastrointestinal symptoms using subjective GI symptom ranking questionnaire [ Time Frame: 6 weeks after daily consumption at breakfast ]
    symptoms include pain, discomfort, bloating & flatulence will be recorded using subjective GI symptom ranking questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels
Official Title  ICMJE The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels: a Randomized, Single-blind, Placebo-controlled, Cross-over Study
Brief Summary The objectives of this study are to examine fecal bacterial population(s) and plasma cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
For each of the two periods, a hot breakfast cereal will be consumed once daily for a duration of 6 weeks each. There will be a 4 week washout period in between each test substance.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Microbiome
  • Plasma Cholesterol
  • Prebiotic
Intervention  ICMJE Other: Hot Cereal
Intervention involves consumption of one hot cereal in the beginning of each day
Study Arms  ICMJE
  • Placebo Comparator: Cereal - Cream of Rice
    40 g cream of rice
    Intervention: Other: Hot Cereal
  • Experimental: Cereal - Oats containing beta-glucan
    40 g oats
    Intervention: Other: Hot Cereal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 16, 2018
Actual Primary Completion Date August 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has given written informed consent;
  2. Be between 18 and 65 years of age;
  3. Has a BMI of between 18.5 - 30 Kg/m2;
  4. Has a stable body weight (< 5% change) over the past 3-months;
  5. Have elevated cholesterol levels, with a total cholesterol level >5.5mmol/L and <7mmol/L; and LDL cholesterol level ≥3.4 mmol/L and ≤4.9 mmol/L.
  6. Is in general good health, as determined by the investigator;
  7. Consumes a low to moderate fiber diet (9.9 - 25.1 g/day in males; 8.2 - 20.3 g/day in females);
  8. Regularly consumes breakfast;
  9. Avoid consuming prebiotic, probiotic or fiber rich supplements within 3 weeks prior to baseline visit, until the end of the study;
  10. Avoid consumption of any whole grain oat products, within 3 weeks prior to baseline visit, until the end of the study;
  11. Agrees to continue to consume the same dose of vitamin and/or mineral supplements, if applicable, for the duration of the study;
  12. Maintain current level of physical activity;
  13. Agree to keep detailed dietary and stool records;
  14. Willing to consume the investigational products daily for the duration of the study.
  15. Subject must have access to a microwave oven

Exclusion Criteria:

  1. Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:

    • non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
    • child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).

      v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study,

  2. Are hypersensitive to any of the components of the test products;
  3. Is Coeliac, or has an intolerance to gluten;
  4. Has taken antibiotics within the previous 3 months;
  5. Has a history of drug and/or alcohol abuse at the time of enrolment;
  6. Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
  7. Is a smoker;
  8. Has a fasting blood glucose level outside the range of 3.0 - 6.0 mmol/L;
  9. Has uncontrolled hypertension (systolic blood pressure ≥159 mm Hg or diastolic blood pressure ≥99 mm Hg);
  10. Has made any major dietary changes in the past 3 months;
  11. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
  12. Has a diagnosed eating disorder;
  13. Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
  14. Taking a medication/supplement that the investigator believes would impart or treat constipation, including iron, Imodium, Colon Clean, chronic or regular laxatives use or dependency on laxatives; and fiber supplements, within 3 weeks prior to baseline visit, until the end of the study;
  15. Has an active gastrointestinal disorder or previous gastrointestinal surgery, other than an appendectomy
  16. If taking chronic medications (e.g., hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;
  17. Subject is on any medication that has an effect on lowering cholesterol, such as use of beta blockers to treat hypertension or anxiety;
  18. Has a metabolic or gastrointestinal diseases (i.e., diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;
  19. Has a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include Statins (including atorvastatin (Lipitor and Torvast), fluvastatin (Lescol), lovastatin (Mevacor, Altocor, Altoprev), pitavastatin (Livalo, Pitava), pravastatin (Pravachol, Selektine, Lipostat), rosuvastatin (Crestor) and simvastatin (Zocor, Lipex)), Cholesterol Absorption Inhibitors (including Zetia (ezetimibe)), Niacin (nicotinic acid), Fibric acid derivatives (including Atromid-S (clofibrate), Lopid (gemfibrozil), and Tricor (fenofibrate)), Bile Acid Sequestrants (including cholestyramine, sold under the brand names Questran, Prevalite, and LoCholest, and colestipol (Colestid)) and Non Steroidal Anti-Inflammatory Drugs (NSAIDs), or have taken them in the past 28 days;
  20. Taking a cholesterol lowering supplement, including, example Plant sterols/stanols, Fish Oil supplements, vitamin B supplements (e.g. Niacin and Niacinamide), red rice yeast extract, oat beta glucan, pharmaceutical garlic or have taken them in the past month;
  21. Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
  22. Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
  23. Have a malignant disease or any concomitant end-stage organ disease;
  24. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
  25. Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03450395
Other Study ID Numbers  ICMJE PEP-1720
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party PepsiCo Global R&D
Study Sponsor  ICMJE PepsiCo Global R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Dinan, MD, PhD Cork University Hospital & APC Microbiome Institute, University College Cork
PRS Account PepsiCo Global R&D
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP