MedTrace Logo

Polyphenol Supplementation and Morbid Obesity Parameters

NCT05428540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-08-09

No results posted yet for this study

Summary

This parallel, double-blind, randomised controlled trial aims to assess the effect of a polyphenol-rich dietary supplement on obesity parameters, in combination with a hypocaloric diet, for adults with morbid obesity, bariatric surgery candidates.

Participants (n=40) will be randomly assigned to intervention group (IG) or control group (CG). Together with a regular hypocaloric diet (1,200 kcal/d), the IG will be given the supplement and the CG will be given a placebo. Both groups will take three capsules a day (400 mg per capsule, a total of 1,200 mg), distributed in three daily intakes (with meals). After 12 weeks and 3 visits (baseline visit, week 6 and week 12), pre and post intervention data and intervention versus placebo data will be analysed. Anthropometric and health parameters, dietary habits, lifestyle characteristics and physical activity will be assessed, and blood and urine samples will be collected in all three visits. Faecal samples will be collected at baseline and visit 3.

Results will provide evidence on the effects of a combination of polyphenols on several well-established obesity parameters and will unravel possible underlying mechanisms by metabolomic analyses and microbiota diversity.

Conditions

  • Morbid Obesity

Interventions

DIETARY_SUPPLEMENT

Polyphenol-rich supplement

Polyphenol-rich capsules containing 1,200 mg of a combination of plant extracts rich in polyphenols. Frequency: 3 capsules a day. Duration: 12 weeks.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2023-06-16
Completion
2023-06-16

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428540 on ClinicalTrials.gov