Microbiota Diversity and Composition and Polyphenol Bioavailability

NCT02677649 | Completed

• 1 other identifier: 2870
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Microbiota

Keywords

cranberry, microbiome, polyphenols, healthy

Outcome Measures

Primary Outcomes (1)

• fecal microbiome

  16S rRNA in feces will be determined to profile microbiome

  The change in fecal microbiome after consuming the intervention diets for 5 days.

Study Arms (2)

cranberry

ACTIVE COMPARATOR

30 grams/day freeze dried whole cranberry powder added to a basal diet comprising meats, dairy products, simple sugars, and stevia

Other: cranberry

placebo

PLACEBO COMPARATOR

30 grams/day placebo powder \[made with maltodextrin (CPC Maltrin M-180), citric acid, artificial cranberry flavor (Lorann oils), fructose, red color (Lorann oils), and grape shade\] added to a basal diet comprising meats, dairy products, simple sugars, and stevia

Other: placebo

Interventions

cranberry OTHER

the effect of cranberry on the gut microbiota

cranberry

placebo OTHER

the effect of placebo on the gut microbiota

placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111, United States

Location

Study Officials

• Oliver Chen, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist I

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 9, 2016
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)