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

NCT05062954 | Unknown DMC

• 1 other identifier: 128976
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (9)

• Changes in basic plasma lipid-lipoprotein profile

  Fasting blood samples

  8 weeks

• Changes in glucose homeostasis

  Fasting blood samples

  8 weeks

• Changes in lipopolysaccharide binding protein (LBP)

  Fasting blood samples

  8 weeks

• Changes in white matter health assessment

  T2-weighted images, axial fluid-attenuated inversion recovery

  8 weeks

• Changes in brain density in key regions

  Structural MRI measurements

  8 weeks

• Changes in functional brain connectivity

  Resting state functional MRI

  8 weeks

• Changes in white matter integrity

  Diffusion tensor imaging

  8 weeks

• Changes in cerebral vasculature

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

  8 weeks

• Gut microbiota composition

  Measures in fecal samples

  8 weeks

Secondary Outcomes (6)

• Changes in executive function

  8 weeks

• Changes in attention span and short-term working memory

  8 weeks

• Changes in cognitive flexibility and speed of information processing

  8 weeks

• Changes in biomarkers of gut endotoxemia

  8 weeks

• Changes in biomarkers of gut permability

  8 weeks

Study Arms (2)

Polyphenol-rich cranberry extract supplement standardized in PACs

EXPERIMENTAL

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

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

Placebo supplement

PLACEBO COMPARATOR

Supplementation with placebo (1 capsule / day)

Dietary Supplement: Placebo supplement

Interventions

Polyphenol-rich cranberry extract supplement standardized in proanthocyanidins DIETARY_SUPPLEMENT

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

Polyphenol-rich cranberry extract supplement standardized in PACs

Placebo supplement DIETARY_SUPPLEMENT

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

Placebo supplement

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Quebec Heart and Lung Institute - Laval University

Québec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Proanthocyanidins

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tannins; Biopolymers; Polymers; Macromolecular Substances

Central Study Contacts

Andréanne Michaud, PhD

CONTACT

418-656-8711; Andreanne.Michaud@fsaa.ulaval.ca

vicky Leblanc, PhD

CONTACT

vicky.leblanc@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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 30, 2021
• Study Start: October 21, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)