An interventional study of Raspberry and fructooligosaccharide and Raspberry in Healthy Subjects and Pre-diabetes, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Completed at 1 site in United States. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Other
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.
The study will be performed as a single-blinded, randomized, crossover manner. Thirty subjects (20 insulin resistant subjects and 10 healthy subjects) will be randomly assigned into one of two sequences: sequence A (n=15) will be RRB then RRB+FOS (which means subject will consume only RRB (125 g/day(d) (equivalent to 1 cup fresh RRB)) with breakfast for 4 weeks, and then after a 4-week washout period, that subject will consume the RRB with FOS (125 g/d RRB and 8 g/d FOS) for 4 weeks); sequence B (n=15) will be RRB+FOS then RRB (which means subject will receive the RRB with FOS for 4 weeks, a 4-week washout, and then the RRB for another 4-week). At the beginning and end of each 4-week treatment, subjects will undergo a 6-h Study Day (4 study days in 12-week study duration) followed by a 1-h next morning follow-up visit.
Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online survey and on-site clinic assessments, including questionnaires, blood analysis and anthropometric measures. Eligible subjects will be invited to participate in the study. Each subject will be asked to come for 1 Screening Visit, 4 dinner pick-ups (the day before each Study Day), 4 Study Days and 6 Weekly Meetings.
During the Screening Visit, subjects will read, sign and date a written Institutional Review Board approved Informed Consent Form prior to performing any study procedure. And then they will be assessed their qualification, instructed on the process for completing study questionnaires and counseled to restrict intake of colored plant foods rich in phytonutrients the 3 days prior to each Study Day. They will be asked to restrict alcohol intake, coffee/tea/ caffeinated beverage intake and moderate / vigorous physical activity and to drink plenty of water to maintain hydration in the 24 h prior to each Study Day. They will be instructed to come to the Clinical Nutrition Research Center (CNRC) the day before each Study Day to pick up their dinner meal and evening snack. Subjects will be asked to get at least 7 hours sleep and to come to the CNRC after a 10-h overnight fasting on each Study Day.
Each Study Day will require subjects to be in the clinic for \~7 h to complete all baseline and post challenge beverage testing procedures, including a 6 h study day and a 1 h next morning follow-up visit. Subjects will be evaluated for compliance with the protocol (diet, exercise, sleep, fasting), have their body weight and blood pressure measured, ingest a cup of red raspberry drink (250 g RRB (equivalent to 2 cups fresh RRB) and 64 g glucose) and their blood, urine and feces samples will be collected.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 30 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g)
Dietary Supplement: Raspberry and fructooligosaccharide
Red raspberries (1 cup equivalent)
Dietary Supplement: Raspberry
Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g)
Red raspberries (1 cup equivalent)
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
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma red raspberry polyphenol metabolites in 12-week intervention of active treatment vs Experimental
Plasma red raspberry polyphenol metabolites
Time frame: 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
Plasma Insulin Sensitivity
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma glucose response in 12-week intervention of active treatment vs Experimental
Plasma glucose response
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma insulin response in 12-week intervention of active treatment vs Experimental
plasma insulin response
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in urine creatinine concentration in 12-week intervention of active treatment vs Experimental
urine creatinine concentration
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in urine red raspberry polyphenol metabolites in 12-week intervention of active treatment vs Experimental
urine red raspberry polyphenol metabolites
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in breath hydrogen exhalation in 12-week intervention of active treatment vs Experimental
breath hydrogen exhalation
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in Gastrointestinal Health as measured by Gastrointestinal Tract Questionnaire in 12-week intervention of active treatment vs Experimental
Gastrointestinal Health
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in blood pressure in 12-week intervention of active treatment vs Experimental
blood pressure
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in body weight in 12-week intervention of active treatment vs Experimental
body weight
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in waist circumference in 12-week intervention of active treatment vs Experimental
waist circumference
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma triglycerides in 12-week intervention of active treatment vs Experimental
plasma triglycerides
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs Experimental
plasma LDL cholesterol
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs Experimental
plasma HDL cholesterol
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
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Clinical Nutrition Research Center, Illinois Institute of Technology