Omega-3 Supplementation After Surgical Treatment of Obesity

NCT ID: NCT06494566

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2023-12-04

Brief Summary

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The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.

Detailed Description

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Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants will be randomized in blocks of two participants, at a 1:1 ratio, for the two groups of treatment. For every two participants, there will be one block. The number of each block will be hold in a nontransparent, seriated, sealed envelope. Intervention capsules will be opaque and stored in identical containers by a single investigator, who will not take part in data collection or analysis.

Study Groups

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Omega-3

Omega-3 2000mg (940mg of EPA and 660mg of DHA) in gastro resistant capsule by mouth once a day for 90 days, starting on day sixteen after surgery.

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

Omega-3 capsule

Placebo

Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery.

Group Type PLACEBO_COMPARATOR

Mineral Oil

Intervention Type DIETARY_SUPPLEMENT

Mineral Oil Capsule

Interventions

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Omega-3

Omega-3 capsule

Intervention Type DIETARY_SUPPLEMENT

Mineral Oil

Mineral Oil Capsule

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI \> 30kg/m2
* Candidate to bariatric and metabolic surgery

Exclusion Criteria

* Use of Omega-3
* Contraindication to bioimpedance analysis
* Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics
* Refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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10311419.5.0000.5333

Identifier Type: -

Identifier Source: org_study_id

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