Red Raspberry Polyphenols on Gut Microbiome

Completed · Not applicable

Conditions studied: Healthy Subjects, Pre-diabetes

In brief

The primary objective aims are to assess the effects of regular consumption of red raspberries (RRB) with and without fructooligosaccharide (FOS) on the composition of the gut microbiota after 4 week intake and in parallel characterize plasma and urine metabolite profiles examining qualitative and quantitative intervention associated changes.

Key facts

Study ID: NCT03049631
Run by: Clinical Nutrition Research Center, Illinois Institute of Technology
People needed: 30
Starts: 2017-05-18
Expected to finish: 2020-07-06
Last updated by the study team: 2020-07-14

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Non-smoking1 man or woman, 20-60 years of age, inclusive
Group 1 must have a fasting blood glucose between 100-125 mg/dL and inulin ≥ 8 μIU/mL
Group 2 will have a fasting blood glucose below 100 mg/dL and the homeostasis model assessment method of insulin resistance (HOMA-IR) [glucose (μmol/L) × insulin (μunits/μL)/22.5] value less than 1
Judged to be in good health on the basis of the medical history
Able to provide informed consent and comply with study procedures
Able to comply to the study instructions (including dietary restrictions, consumption of study beverage, records of food diary and GI-tract questionnaire, sample collection procedure and study visit schedule)
Able to maintain your usual physical activity pattern
Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during study visit

You may not qualify if…

Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening visit.
Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
Weight change ≥4.5 kg (9.9 lbs) within 2 months
Presence of chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
Had gastrointestinal barium opaque meal within 3 months
History or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary that, in the opinion of the investigator, could interfere with the interpretation of the study results
History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
History of extreme dietary habits, as judged by the investigator (e.g., Atkins diet, etc.)
History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
Vegan or other extreme dietary regimens as judged by the investigator.
Has a known intolerance or sensitivity to any ingredients in the study products
Has used antibiotics within the previous 2 months
Has used prebiotics, probiotics, or drugs active on gastrointestinal motility, or a laxative of any class within 1 month
Has used medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids within 2 weeks
Female, who is pregnant, lactating or planning pregnancy during the study period
Has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
Donated blood within last 3 months
Working overnight (e.g. 3rd shift)
Excessive coffee and tea consumption (> 4 cups/day)
Men and women who do excessive exercise regularly or athlete
Men and women whom investigator is uncertain about subject's capability or willingness to comply with protocol requirement

Where it is running

Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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