Omega-3 Supplementation After Surgical Treatment of Obesity

Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06494566

Enrollment

150

Registered

2024-07-10

Start date

2019-04-10

Completion date

2023-12-04

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Sarcopenia, Lipid profile, Bariatric surgery, Metabolic surgery

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTOmega-3

Omega-3 capsule

DIETARY_SUPPLEMENTMineral Oil

Mineral Oil Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Weight	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Measurement with digital scale, patient standing, barefoot. kilograms (kg)
Height	Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Height measurement, patient standing, barefoot. Unit of measurement: meters (m).

Secondary

Measure	Time frame	Description
Manual Grip Strength	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf).
6-Minute Walk Test	Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.	Walking with measurements of distance covered. Units of measurement: meters.
Electrical Bioimpedance - Percentage of muscle mass	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).
Electrical Bioimpedance - Body fat percentage	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026