Healthy SubjectsRRB2NCT03049631
Red Raspberry Polyphenols on Gut Microbiome
A study testing Raspberry and fructooligosaccharide and Raspberry in people with Healthy Subjects and Pre-diabetes, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Pre-diabetes
- What is being tested?
- Raspberry and fructooligosaccharide and Raspberry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2017to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: The Reciprocal Interactions Between Red Raspberry Polyphenols and Gut Microbiome Composition Affect Insulin Sensitivity
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.
Read the detailed description
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.
- Conditions
- Healthy Subjects, Pre-diabetes
- Being tested
- Raspberry and fructooligosaccharide, Raspberry
- Keywords
- Pre-diabetes, red raspberry, fructooligosaccharide, metagenomics, polyphenol bioavailability, glycemic response, insulin response
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raspberry and fructooligosaccharideDietary supplement
Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g)
RaspberryDietary supplement
Red raspberries (1 cup equivalent)
| Study group | Role | What they receive |
|---|---|---|
| Raspberry and fructooligosaccharide | Active comparator | Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g) Receives: Dietary Supplement: Raspberry and fructooligosaccharide |
| Raspberry | Experimental | Red raspberries (1 cup equivalent) Receives: Dietary Supplement: Raspberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Plasma red raspberry polyphenol metabolites
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in blood pressure in 12-week intervention of active treatment vs Experimental
blood pressure
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start18 May 2017
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt M Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049631
- Sponsor's protocol ID
- IRB2016-136
- Acronym
- RRB2
- Status last verified
- Jul 2020
- First submitted
- 8 Feb 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35421233
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reciprocal Interactions Between Red Raspberry Polyphenols and Gut Microbiome Composition Affect Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT03049631
- Acronym / sponsor ID
- RRB2 / IRB2016-136
- Conditions
- Healthy Subjects, Pre-diabetes
- Keywords
- Pre-diabetes, red raspberry, fructooligosaccharide, metagenomics, polyphenol bioavailability, glycemic response, insulin response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raspberry and fructooligosaccharide | Active comparator | Dietary Supplement: Raspberry and fructooligosaccharideRed raspberries (1 cup equivalent) with fructooligosaccharide (8 g) |
| Raspberry | Experimental | Dietary Supplement: RaspberryRed raspberries (1 cup equivalent) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raspberry and fructooligosaccharideRed raspberries (1 cup equivalent) with fructooligosaccharide (8 g) | Dietary supplement | Raspberry and fructooligosaccharide |
| RaspberryRed raspberries (1 cup equivalent) | Dietary supplement | Raspberry |
Primary outcome
Changes in gut microbiome composition as measured by 16S rRNA gene sequencing in 12-week intervention of active treatment vs Experimental
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
gut microbiome composition changes
9 secondary outcomes
Changes in plasma red raspberry polyphenol metabolites in 12-week intervention of active treatment vs Experimental
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
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma glucose response in 12-week intervention of active treatment vs Experimental
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in plasma insulin response in 12-week intervention of active treatment vs Experimental
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in urine creatinine concentration in 12-week intervention of active treatment vs Experimental
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
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in breath hydrogen exhalation in 12-week intervention of active treatment vs Experimental
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
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Changes in blood pressure in 12-week intervention of active treatment vs Experimental
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 35421233Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt M Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raspberry and fructooligosaccharide and Raspberry in people with Healthy Subjects and Pre-diabetes, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiome composition as measured by 16S rRNA gene sequencing in 12-week intervention of active treatment vs Experimental (time frame: baseline, 4 weeks, 8 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.