Red Raspberry Polyphenols on Gut Microbiome

NCT03049631 | Completed

• 1 other identifier: IRB2016-136
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects; Pre-diabetes

Keywords

Pre-diabetes; red raspberry; fructooligosaccharide; metagenomics; polyphenol bioavailability; glycemic response; insulin response

Outcome Measures

Primary Outcomes (1)

• Changes in gut microbiome composition as measured by 16S rRNA gene sequencing in 12-week intervention of active treatment vs Experimental

  gut microbiome composition changes

  baseline, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (9)

• Changes in plasma red raspberry polyphenol metabolites in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI) in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in plasma glucose response in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in plasma insulin response in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in urine creatinine concentration in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

Other Outcomes (5)

• Changes in body weight in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in waist circumference in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in plasma triglycerides in 12-week intervention of active treatment vs Experimental

  baseline, 4 weeks, 8 weeks and 12 weeks

Study Arms (2)

Raspberry and fructooligosaccharide

ACTIVE COMPARATOR

Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g)

Dietary Supplement: Raspberry and fructooligosaccharide

Raspberry

EXPERIMENTAL

Red raspberries (1 cup equivalent)

Dietary Supplement: Raspberry

Interventions

Raspberry and fructooligosaccharide DIETARY_SUPPLEMENT

Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g)

Raspberry and fructooligosaccharide

Raspberry DIETARY_SUPPLEMENT

Red raspberries (1 cup equivalent)

Raspberry

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• Zhang X, Zhao A, Sandhu AK, Edirisinghe I, Burton-Freeman BM. Red Raspberry and Fructo-Oligosaccharide Supplementation, Metabolic Biomarkers, and the Gut Microbiota in Adults with Prediabetes: A Randomized Crossover Clinical Trial. J Nutr. 2022 Jun 9;152(6):1438-1449. doi: 10.1093/jn/nxac037.

  PMID: 35421233 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

fructooligosaccharide

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Britt M Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: May 18, 2017
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)