Microbiota Diversity and Composition and Polyphenol Bioavailability

Completed · Not applicable · Has a placebo group

Conditions studied: Fecal Microbiota

In brief

Composition and diversity of intestinal microbiota that are subject to the influence of diet have a significant impact on health in the gut and whole body via complex interactions between food constituents, bacteria, and host. Polyphenols are poorly absorbed in the upper gastrointestinal tract and reach the colon, where they may have a reciprocal relationship with microbiota. Because how polyphenols mediate gut health and reduce risk for other pathogenesis remains to be elucidated, we propose to conduct a pilot controlled feeding study to examine the impact of polyphenols and other constituents in the free dried whole cranberry powder (FWCP) on composition and diversity of gut microbiota, as well as to substantiate bioavailability of cranberry polyphenols. The central hypothesis underlying the proposed research is that FWCP polyphenols will diminish the magnitude of a plant food free diet induced increase in Alistipes, Bilophila and Bacteroides and will increase Enterococcus, Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale groups. The proposed research is novel as no study has examined the specific impact of FWCP polyphenols incorporated into a plant food free diet on gut microbiota. This proposed study is innovative because the positive results will demonstrate with a high degree of confidence that the impact of FWCP constituents on production of beneficial short chain fatty acids, carcinogenic bile acids, and atherogenic trimethylamine. The results generated from the study using a plant food free dietary regimen as the background diet will provide definite proof on microbial modulating actions of FWCP, inform mechanism of actions in urinary tract infection (UTI), and be used to formulate messages in consumer communications for gut health.

Key facts

Study ID: NCT02677649
Run by: Tufts University
People needed: 11
Starts: 2015-12-01
Expected to finish: 2016-08-01
Last updated by the study team: 2017-02-23

Who can join

Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age between 20-55 y
BMI between 18.5-29.9 kg/m2
Bowel movement ≥3 times/wk
Consume ≥3 servings of fruits and vegetables daily on average
Willing to consume animal based diets for ≥10 days
Willing to consume freeze-dried whole cranberry powder
Willing to not take prebiotics and probiotics during the trial
Do not have allergic reaction to cranberries

You may not qualify if…

Colonoscopy 2 mo prior to their enrollment or scheduled during the study
No antibiotic medications or drugs known to influence fecal microbiota were taken or used 3 mo before the study
History of a bilateral mastectomy
History of autoimmune disorders (rheumatoid arthritis, lupus, multiple sclerosis, vitiligo, psoriasis)
Consume <3 servings of fruits and vegetables daily one average
Gastrointestinal diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease or inflammatory bowel disease which will be found based on the self-report during the screening visit
Regular use of any acid-lowering medications (≥3 times/week)
Use of ≥14/wk serving of alcohol (168 oz beer, 56 oz wine, 14 oz hard liquor)
Intend to be pregnant, pregnancy, and breastfeeding
Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
Active treatment for cancer (except non-melanom skin cancer) and cardiovascular disease of any type >1 y
Having diabetes and/or receiving medications for diabetic condition, which will be found based on the self-report during the screening visit
Thyroid disease unstable or medication adjustments in past 6 months, which will be found based on the self-report during the screening visit
Values of standard blood biochemistries are unacceptable for the study based on study physician's discretion
vegetarians and vegans, unwillingness or inability to consume animal-based foods including chicken, turkey, beef, eggs, cheese, other milk products, etc. Allergy to eggs or milk/dairy products.
Use anticoagulants, such as heparin, warfarin (coumadin) in past 6 months
On or planning to be on a weight loss regimen
Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements at enrollment and throughout the entire study may be considered eligible
Use of monoamine oxidase inhibitors (MAOIs)
Glomerular filtration rate (GFR) <60 mL/min/1.73 m2
Total cholesterol (TC) >250 mg/dL
Total triglycerides (TG) >300 mg/dL

Where it is running

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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