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NCT Number: NCT07460856

Effects of Cranberry on Gut and Metabolic Health

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INAF, Université Laval

Québec, Quebec, G1V0A6, Canada

Location status: Recruiting

Location contact

Julie Marois, M.Sc.

CONTACT

[email protected]

1-418-656-5258

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cranberry beverage

Dietary Supplement

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

Placebo Beverage

Dietary Supplement

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Change in lipid profile

    Time frame: Pre and post each treatment (12 week/each)

    Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol

Secondary outcomes

  1. Change in other measures of glucose homeostasis

    Time frame: Pre and post each treatment (12 week/each)

    Assessment of glycated hemoglobin (HbA1c)

  2. Change in blood pressure

    Time frame: Pre and post each treatment (12 week/each)

    Assessment of systolic and diastolic blood pressure

  3. 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

  4. 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

  5. Change in anthropometric measurements

    Time frame: Pre and post each treatment (12 week/each)

    Assessment of waist circumference

  6. 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

  7. Change in gut microbiota

    Time frame: Pre and post each treatment (12 week/each)

    Assessment of global variation of the fecal microbiota

  8. Change in gut microbiota function

    Time frame: Pre and post each treatment (12 week/each)

    Assessment of short-chain fatty acid (SCFA) in feces

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Marois, M.Sc.

CONTACT

[email protected]

1-418-656-5258

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Ocean Spray Cranberries, Inc.

Registry information

Acronym: CRANOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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