Omega-3 Supplementation After Surgical Treatment of Obesity

NCT06494566 | Completed Early Phase 1 DMC

• 1 other identifier: 10311419.5.0000.5333
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Sarcopenia; Lipid profile; Bariatric surgery; Metabolic surgery

Outcome Measures

Primary Outcomes (2)

• Weight

  Measurement with digital scale, patient standing, barefoot. kilograms (kg)

  Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

• Height

  Height measurement, patient standing, barefoot. Unit of measurement: meters (m).

  Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

Secondary Outcomes (4)

• Manual Grip Strength

  Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

• 6-Minute Walk Test

  Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.

• 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 - Body fat percentage

  Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

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.

Dietary Supplement: Omega-3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Mineral Oil

Interventions

Omega-3 DIETARY_SUPPLEMENT

Omega-3 capsule

Omega-3

Mineral Oil DIETARY_SUPPLEMENT

Mineral Oil Capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (2)

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-072, Brazil

Location

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, 90040-371, Brazil

Location

MeSH Terms

Conditions

Obesity; Sarcopenia

Interventions

Docosahexaenoic Acids; Mineral Oil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Petrolatum; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 10, 2024
• Study Start: April 10, 2019
• Primary Completion: July 30, 2023
• Study Completion: December 4, 2023
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)