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NCT03659240 Clinical Trial

Prebiotic Effects of a Polyphenol-rich Food Product

Dysbiosis Clinical Trial

Official title:
Prebiotic Effects of a Polyphenol-rich Food Product

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03659240
Other study ID # 18-303-00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 9, 2018
Est. completion date February 24, 2019

Study information
Verified date February 2023
Source Iowa State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date February 24, 2019
Est. primary completion date February 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - BMI 27-35 kg/m2 - High waist circumference (men >102 cm and women >88 cm) Exclusion Criteria: - Cigarette smoking - Regular intensive exercise - Pregnancy or lactation - Chronic diarrhea, constipation, or other gastrointestinal complaint - Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota - Use of medications that affect inflammation or the gut microbiota - Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota - Aversion to cranberries - Food allergies - Lactose intolerance - Vegetarianism

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cranberry beverage
During the intervention period, research participants will consume a cranberry beverage daily.
• Placebo beverage
During the intervention period, research participants will consume a placebo beverage daily.

Locations
Country Name City State
United States Nutrition and Wellness Research Center Ames Iowa

Sponsors (1)
Lead Sponsor Collaborator
Iowa State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fecal microbial community composition and structure We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage. Changes in the fecal microbiota will be measured after a 20-day intervention period
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