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Completed
NCT05062954
Effects of a Polyphenol-rich Cranberry Extract on Cardiometabolic and Neurocognitive Health
Conditions: Abdominal Obesity
Sex: All
Ages: 30 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 49
Sponsor: Laval University
Location: Quebec Heart and Lung Institute - Laval University Québec Quebec
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.
Eligibility Criteria
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:
* 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.
Source: ClinicalTrials.gov (NCT05062954). StuddyBuddy aggregates publicly available trial information.