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CompletedNCT05062954NeurocanUpdated Aug 26, 2026

Effects of a Polyphenol-rich Cranberry Extract on Cardiometabolic and Neurocognitive Health

An interventional study of Polyphenol-rich cranberry extract supplement standardized in proanthocyanidins and Placebo supplement in Abdominal Obesity, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Laval University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

The objective of this double-blind, parallel, randomized placebo-controlled clinical trial is to evaluate the effects of consumption of polyphenol-rich cranberry extract standardized in PACs (36 mg PACs/capsule) on cardiometabolic and neurocognitive health in women and men presenting abdominal obesity over an 8-week intervention period.

The study will be conducted at Quebec Heart and Lung Institute - Laval University. The study will involve a total of 60 adult men and women presenting abdominal obesity. Included participants will be randomly assigned to the consumption of a cranberry extract or a placebo at a rate of one capsule per day for 8 weeks (56 days). The main outcomes are changes in metabolic profile, neurocognitive performance as well as brain structure and function following polyphenol-rich cranberry extract standardized in PACs compared with the placebo.

Read the detailed description

Background :

Abdominal obesity is associated with impaired cognitive function and increased risk of neurodegenerative diseases. The metabolic disorders associated with obesity may lead to alterations in brain function and structure, explaining the link between obesity and some cognitive dysfunction. Magnetic resonance imaging (MRI) studies show that obese individuals are characterized by gray matter atrophy in brain regions involved in self-control. Atrophy and alteration of white matter fibers have also been observed in these individuals. However, the mechanisms explaining these changes are not yet elucidated. It has been suggested that metabolic and inflammatory alterations associated with abdominal obesity may lead to these brain alterations.

It is well known that dietary intake influences the composition and diversity of the gut microbiota and that its disruption plays a central role in the development of obesity, chronic low-grade inflammation, insulin resistance and cardiovascular disease. Some studies have reported improvements in blood pressure, lipid profile, glucose homeostasis, endothelial function, arterial stiffness and inflammation following cranberry consumption, but others found no significant changes. A recent meta-analysis reported that taking a polyphenol-rich supplement is associated with improved cognitive function in young adults. Although the mechanisms underlying the beneficial effects of polyphenols on brain function and cognition remain to be elucidated, some studies suggest that these effects may be associated with their anti-inflammatory and antioxidant properties and their possible effect on the cerebrovascular system. To our knowledge, there are no randomized controlled studies that have evaluated the effects of polyphenol-rich cranberry extract standardized in PACs on neurometabolic and neurocognitive functions in participants with abdominal obesity.

Objectives and Hypothesis:

The objective of this double-blind, randomized placebo-controlled clinical trial is to evaluate the effects of consumption of polyphenol-rich cranberry extract standardized in PACs (36 mg PACs/capsule) on cardiometabolic and neurocognitive health in abdominally obese women and men over an 8-week period.

The overall hypothesis is that standardized extract of PACs from cranberry improves the metabolic profiles in abdominally obese individuals and this will have a beneficial impact on brain and neurocognitive functions.

Methodology:

Sixty men and women with a BMI equal or greater than 25 kg/m2 and an altered blood lipid profile (triglycerides) will be recruited at the IUCPQ-Université Laval via social networks and Laval University's recall lists. The study will include 3 visits to the IUCPQ-Université Laval as well as the consumption of a cranberry extract or a placebo at a rate of one capsule per day for 8 weeks (56 days). The eligibility visit (V1) consists of completing a medical history questionnaire, and anthropometric and fasting blood lipid measurements. Individuals eligible to participate will then be invited to 2 identical visits at the IUCPQ-Université Laval (V2 and V3). At visit 2, cognitive tasks, anthropometric measurements, blood pressure, MRI (Philips 3T) and a pan-body DXA will be performed in all participants. Cognitive function will be measured using a battery of validated neurocognitive tasks. On the morning of each MRI session, fasting blood samples will be collected. Stool samples will be collected by participants prior to each visit 2 and 3 to measure microbiota composition. Following visit 2, participants will leave with capsules of cranberry extract containing 36 mg of PACS or a placebo (double-blind randomization) and will be asked to consume one capsule per day for 56 consecutive days. They will return for the 3rd visit (identical to V2) 8 weeks after starting the supplements. Dietary and physical activity questionnaires will also be completed online before visits 2 and 3. At the beginning of the visits, any changes in the participant's health condition and use of medications and natural health products will be documented. A follow-up phone call will be scheduled with each participant on day 28 of the intervention to ensure that the intervention is going well. Adverse events related to supplementation will be documented. An end-of-study questionnaire will be completed by the participant at the last visit (V3) to confirm study blinding. Participants will be asked to report the remaining capsules at the last visit (V3), which will allow assessment of compliance with the intervention.

02

Conditions studied

  • Abdominal Obesity

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03

In context

Obesity, Abdominal

274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.

This study's enrollment of 49 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.

Browse Obesity, Abdominal studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men and women aged between 30-70 years old;
  • BMI equal or greater than 25 kg/m2;
  • Waist circumference ≥85 cm for women, ≥90 cm for men;
  • Stable weight in the past 3 months;
  • Plasma triglycerides levels ≥1.5 mmol/L for men and women;
  • Access to a computer and Internet.

Exclusion criteria

Exclusion criteria:

  • Any severe uncontrolled medical, surgical, neurological or psychiatric condition;
  • Medication for dyslipidemias, CVD, T2D or obesity;
  • Medication that may affect the CNS;
  • Gastro-intestinal conditions or disorders likely to impact on absorption;
  • History of nephrolithiasis or urolithiasis;
  • Contraindications to MRI (cardiac pacemaker/defibrillator, cochlear implant or other ear implant, implanted insulin pump or other infusion pump systems, neurostimulator or other electronic/magnetic implant or device, any type of prothesis, aneurysm clips, any metallic fragments, vascular access port, catheter, dental retainer, claustrophobia, surgery in the last 3 months);
  • Anticoagulant/blood thinning medication in the last month;
  • Pregnant or breastfeeding women;
  • Substance or alcohol abuse;
  • Known allergy or intolerance to cranberry;
  • Currently smoking.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Polyphenol-rich cranberry extract supplement standardized in PACs

    Supplementation with polyphenol-rich cranberry extract standardized in PACs (1 capsule / day)

    Dietary Supplement: Polyphenol-rich cranberry extract supplement standardized in proanthocyanidins

  • Placebo comparator
    Placebo supplement

    Supplementation with placebo (1 capsule / day)

    Dietary Supplement: Placebo supplement

Interventions

  • Dietary supplementPolyphenol-rich cranberry extract supplement standardized in proanthocyanidins

    Participants will be randomly assigned to the consumption of one capsule of Polyphenol-rich cranberry extract standardized in PACs.

  • Dietary supplementPlacebo supplement

    Participants will be randomly assigned to the consumption of one capsule of placebo per day for 56 consecutive days.

06

What researchers measure

Primary outcomes

  1. Changes in glucose homeostasis

    HOMA-IR

    Time frame: 8 weeks

  2. Changes in basic plasma lipid-lipoprotein profile

    Fasting blood samples

    Time frame: 8 weeks

  3. Changes in glucose homeostasis

    Change in fasting glucose

    Time frame: 8 weeks

Secondary outcomes

  1. Changes in executive function

    Stroop

    Time frame: 8 weeks

  2. Changes in attention span and short-term working memory

    Digit Span

    Time frame: 8 weeks

  3. Changes in cognitive flexibility and speed of information processing

    Trail Making Test (Parts A and B)

    Time frame: 8 weeks

  4. Changes in lipopolysaccharide binding protein (LBP)

    Fasting blood samples

    Time frame: 8 weeks

  5. Changes in biomarkers of gut endotoxemia

    Blood plasma samples will be analysed for presence of lipopolysaccharide (LPS)

    Time frame: 8 weeks

  6. Gut microbiota composition

    Measures in fecal samples

    Time frame: 8 weeks

  7. Changes in cerebral vasculature

    Magnetic resonance angiography time-of-flight (MRA-TOF)

    Time frame: 8 weeks

  8. Changes in white matter health assessment

    T2-weighted images, axial fluid-attenuated inversion recovery

    Time frame: 8 weeks

  9. Changes in biomarkers of gut permability

    Blood plasma samples will be analysed for presence of zonulin

    Time frame: 8 weeks

  10. Changes in white matter integrity

    Diffusion tensor imaging

    Time frame: 8 weeks

  11. Changes in functional brain connectivity

    Resting state functional MRI

    Time frame: 8 weeks

  12. Changes in brain density in key regions

    Structural MRI measurements

    Time frame: 8 weeks

  13. Changes in body fat distribution

    Abdominal axial T1-weighted slices

    Time frame: 8 weeks

07

Study locations

1 site
  • Quebec Heart and Lung Institute - Laval University
    Québec, Quebec G1V 4G5, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05062954
Lead sponsor
Laval University
Responsible party
Sponsor
First posted
Sep 30, 2021
Start date
Oct 21, 2021
Primary completion
Jan 9, 2025
Completion
Jan 9, 2025
Last update
Aug 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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