Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450395
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

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.

Condition or disease Intervention/treatment Phase
Microbiome Plasma Cholesterol Prebiotic Other: Hot Cereal Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
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
Official Title: 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
Actual Study Start Date : January 28, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Cereal - Cream of Rice
40 g cream of rice
Other: Hot Cereal
Intervention involves consumption of one hot cereal in the beginning of each day

Experimental: Cereal - Oats containing beta-glucan
40 g oats
Other: Hot Cereal
Intervention involves consumption of one hot cereal in the beginning of each day




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. fecal Bile Salt Hydrolase [ Time Frame: 6 weeks after daily consumption at breakfast ]
  2. fecal bile acid profile change [ Time Frame: 6 weeks after daily consumption at breakfast ]
  3. fecal bacterial diversity change [ Time Frame: 6 weeks after daily consumption at breakfast ]
  4. Change in serum FGF-19 [ Time Frame: 6 weeks after daily consumption at breakfast ]
  5. Change in plasma total Cholesterol [ Time Frame: 6 weeks after daily consumption at breakfast ]
  6. Change in Plasma HDL Cholesterol [ Time Frame: 6 weeks after daily consumption at breakfast ]
  7. Change in Plasma LDL Cholesterol [ Time Frame: 6 weeks after daily consumption at breakfast ]
  8. Change in Plasma Triglycerides [ Time Frame: 6 weeks after daily consumption at breakfast ]
  9. Change in Plasma Propionate [ Time Frame: 6 weeks after daily consumption at breakfast ]
  10. stool frequency (daily bowel movements) [ Time Frame: 6 weeks after daily consumption at breakfast ]
  11. Change in stool consistency based on 'Bristol' Stool Scale [ Time Frame: 6 weeks after daily consumption at breakfast ]
    using Bristol Stool Scale

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450395


Contacts
Layout table for location contacts
Contact: Andrea Doolan +353 (0)21 423 1000 adoolan@atlantiafoodtrials.com

Locations
Layout table for location information
Ireland
Atlantia Food Clinical Trials Recruiting
Cork, Ireland, T12 H2TK
Contact: Andrea Doolan    +353 (0)21 423 1000    adoolan@atlantiafoodtrials.com   
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
Layout table for investigator information
Principal Investigator: Timothy Dinan, MD, PhD Cork University Hospital & APC Microbiome Institute, University College Cork

Layout table for additonal information
Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03450395     History of Changes
Other Study ID Numbers: PEP-1720
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases