- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460856
Effects of Cranberry on Gut and Metabolic Health (CRANOS)
The consumption of plant-based foods, particularly berries, has been associated with improved health due to their high content of bioactive compounds. Among these, polyphenols-especially proanthocyanidins (PACs)-may offer protective effects against chronic diseases related to overweight and obesity. Cranberries are naturally rich in PACs and may positively influence metabolic health by modulating the gut microbiota. However, their specific effects on intestinal integrity and broader metabolic outcomes remain underexplored.
The primary aim of this study is to assess the effects of cranberry supplementation on glucose metabolism, insulin sensitivity, blood lipid levels, and the composition and function of the gut microbiota in overweight and obese individuals.
This randomized, double-blind, placebo-controlled, crossover clinical trial will include two 12-week intervention periods-one with a cranberry beverage and one with a placebo-separated by a 4-week washout period and preceded by a 2-week lifestyle stabilization phase. Participants will undergo comprehensive metabolic assessments (glucose control, insulin sensitivity, lipid profile), body composition analysis, gut microbiota profiling, and liver fat imaging (MRI in a subsample of female participants). Additional evaluations will include markers of inflammation, appetite regulation, intestinal health, and lifestyle factors.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julie Marois, M.Sc.
- Phone Number: 1-418-656-5258
- Email: julie.marois@fsaa.ulaval.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V0A6
- Recruiting
- INAF, Université Laval
-
Contact:
- Julie Marois, M.Sc.
- Phone Number: 1-418-656-5258
- Email: julie.marois@fsaa.ulaval.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- body mass index between 25 and 40 kg/m2
- at least one of the following criteria: fasting plasma insulin >60 pmol/L, fasting glycemia between 5.5 and 6.9 mmol/L, glycated hemoglobin (HbA1c) level of 5.7- 6.4% and/or fasting triglyceride >1.35 mmol/L.
Exclusion Criteria:
- to have aversion to cranberry products
- regularly drinking alcohol (>2 glasses/day)
- having a significant change in body weight in the past 3 months (±5% of their body weight) due to bariatric surgery or other conditions
- taking medication which may affect the study outcomes (i.e. antidiabetic and/or cholesterol or lipid-lowering medications and/or glucocorticosteroid in supraphysiological doses and/or anti-obesity medications)
- taking regular probiotics and prebiotics (including fruit/berry polyphenol supplements) in the past 3 months
- having eating disorders
- had undergone major surgery 3 months prior to the study or if they had one planned
- if they had intestinal malabsorption, cirrhosis or chronic kidney disease
- being pregnant, planning a pregnancy, or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo beverage
|
Daily consumption of 240 ml of placebo beverage for 12 weeks.
|
|
Experimental: Cranberry beverage
|
Daily consumption of 240 ml of cranberry beverage for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in glucose homeostasis
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of glucose concentrations during a 3-hour oral glucose tolerance test (OGTT)
|
Pre and post each treatment (12 week/each)
|
|
Change in insulin secretion
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of insulin a concentrations during a 3-hour oral glucose tolerance test (OGTT)
|
Pre and post each treatment (12 week/each)
|
|
Change in insulin secretion
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of C-Peptide concentrations during a 3-hour oral glucose tolerance test (OGTT)
|
Pre and post each treatment (12 week/each)
|
|
Change in lipid profile
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
|
Pre and post each treatment (12 week/each)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in other measures of glucose homeostasis
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of glycated hemoglobin (HbA1c)
|
Pre and post each treatment (12 week/each)
|
|
Change in blood pressure
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of systolic and diastolic blood pressure
|
Pre and post each treatment (12 week/each)
|
|
Change in chronic inflammation
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations
|
Pre and post each treatment (12 week/each)
|
|
Change in anthropometric measurements
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of body mass index (BMI) using weight and height.
These two measurements will be combined to calculate BMI in kg/m2
|
Pre and post each treatment (12 week/each)
|
|
Change in anthropometric measurements
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of waist circumference
|
Pre and post each treatment (12 week/each)
|
|
Change in body composition
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan
|
Pre and post each treatment (12 week/each)
|
|
Change in gut microbiota
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of global variation of the fecal microbiota
|
Pre and post each treatment (12 week/each)
|
|
Change in gut microbiota function
Time Frame: Pre and post each treatment (12 week/each)
|
Assessment of short-chain fatty acid (SCFA) in feces
|
Pre and post each treatment (12 week/each)
|
|
Change in fat accumulation in the liver
Time Frame: Pre and post each treatment (12 week/each)
|
Evaluation of fat accumulation using magnetic resonance imaging (MRI) in a subgroup of women only.
|
Pre and post each treatment (12 week/each)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRANOS 2024-530
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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