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Recruiting NCT07460856

Effects of Cranberry on Gut and Metabolic Health

No phase Interventional Overweight/Obesity Metabolic Syndrome Insulin Resistance Microbiota

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cranberry beverage, Placebo beverage.
Who it may be relevant to
Registry conditions: Overweight/Obesity, Metabolic Syndrome, Insulin Resistance, Microbiota. Basic parameters: 25 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement Cranberry beverage
    Daily consumption of 240 ml of cranberry beverage for 12 weeks.
  • Dietary supplement Placebo beverage
    Daily consumption of 240 ml of placebo beverage for 12 weeks.

Primary outcome measures

  • Change in glucose homeostasis [Time frame: Pre and post each treatment (12 week/each)]
  • Change in insulin secretion [Time frame: Pre and post each treatment (12 week/each)]
  • Change in insulin secretion [Time frame: Pre and post each treatment (12 week/each)]
  • Change in lipid profile [Time frame: Pre and post each treatment (12 week/each)]
Secondary outcome measures (9)
  • Change in other measures of glucose homeostasis [Time frame: Pre and post each treatment (12 week/each)]
  • Change in blood pressure [Time frame: Pre and post each treatment (12 week/each)]
  • Change in chronic inflammation [Time frame: Pre and post each treatment (12 week/each)]
  • Change in anthropometric measurements [Time frame: Pre and post each treatment (12 week/each)]
  • Change in anthropometric measurements [Time frame: Pre and post each treatment (12 week/each)]
  • Change in body composition [Time frame: Pre and post each treatment (12 week/each)]
  • Change in gut microbiota [Time frame: Pre and post each treatment (12 week/each)]
  • Change in gut microbiota function [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 1 center
  • INAF, Université Laval — Québec

Identifiers

NCT: NCT07460856 · CRANOS 2024-530

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗