Red Raspberry Polyphenols on Gut Microbiome (RRB2)

This is an interventional other trial for Healthy Subjects focused on measuring Pre-diabetes, red raspberry, fructooligosaccharide, metagenomics, polyphenol bioavailability, glycemic response, insulin response Read More

Inclusion Criteria:

1. Non-smoking1 man or woman, 20-60 years of age, inclusive
2. Group 1 must have a fasting blood glucose between 100-125 mg/dL and inulin ≥ 8 μIU/mL
3. 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
4. Judged to be in good health on the basis of the medical history
5. Able to provide informed consent and comply with study procedures
6. 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)
7. Able to maintain your usual physical activity pattern
8. Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during study visit

Exclusion Criteria:

1. Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening visit.
2. Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
3. Weight change ≥4.5 kg (9.9 lbs) within 2 months
4. Presence of chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
5. Had gastrointestinal barium opaque meal within 3 months
6. 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
7. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
8. History of extreme dietary habits, as judged by the investigator (e.g., Atkins diet, etc.)
9. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
10. Vegan or other extreme dietary regimens as judged by the investigator.
11. Has a known intolerance or sensitivity to any ingredients in the study products
12. Has used antibiotics within the previous 2 months
13. Has used prebiotics, probiotics, or drugs active on gastrointestinal motility, or a laxative of any class within 1 month
14. Has used medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids within 2 weeks
15. Female, who is pregnant, lactating or planning pregnancy during the study period
16. Has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
17. Donated blood within last 3 months
18. Working overnight (e.g. 3rd shift)
19. Excessive coffee and tea consumption (> 4 cups/day)
20. Men and women who do excessive exercise regularly or athlete
21. Men and women whom investigator is uncertain about subject's capability or willingness to comply with protocol requirement