Effects of Cranberry on Gut and Metabolic Health

NCT07460856 | Recruiting

• 1 other identifier: CRANOS 2024-530
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight/Obesity; Metabolic Syndrome; Insulin Resistance; Microbiota

Outcome Measures

Primary Outcomes (4)

• Change in glucose homeostasis

  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

  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

  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

  Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol

  Pre and post each treatment (12 week/each)

Secondary Outcomes (9)

• Change in other measures of glucose homeostasis

  Pre and post each treatment (12 week/each)

• Change in blood pressure

  Pre and post each treatment (12 week/each)

• Change in chronic inflammation

  Pre and post each treatment (12 week/each)

• Change in anthropometric measurements

  Pre and post each treatment (12 week/each)

• Change in anthropometric measurements

  Pre and post each treatment (12 week/each)

Study Arms (2)

Cranberry beverage

EXPERIMENTAL

Dietary Supplement: Cranberry beverage

Placebo beverage

PLACEBO COMPARATOR

Dietary Supplement: Placebo beverage

Interventions

Cranberry beverage DIETARY_SUPPLEMENT

Daily consumption of 240 ml of cranberry beverage for 12 weeks.

Cranberry beverage

Placebo beverage DIETARY_SUPPLEMENT

Daily consumption of 240 ml of placebo beverage for 12 weeks.

Placebo beverage

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Ocean Spray Cranberries, Inc.: collaborator

Study Sites (1)

INAF, Université Laval

Québec, Quebec, G1V0A6, Canada

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Central Study Contacts

Julie Marois, M.Sc.

CONTACT

1-418-656-5258; julie.marois@fsaa.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 10, 2026
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CA (1)