A pilot trial assessing the effect of fish oil on leptin and adiponectin levels in overweight/obese individuals.

Phase 1

Recruiting

• Conditions: Obesity; Cardiovascular Disease; Diet and Nutrition - Obesity; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12610000983000
• Lead Sponsor: Centre for Integrative Clinical and Molecular Medicine, University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Participants will have a BMI of 25 or greater and be generally healthy.

Exclusion Criteria

Concurrent use of other medications or investigational products;
Weight loss of more than 10% body weight within the last six months;
Active substance abuse (alcohol or drug dependency);
Breast feeding or pregnancy;
Smoking;
Allergies to fish oil supplements;
Major Health Conditions;
Concomitant use of anticoagulants or statin medications (Pravastatin).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in adiponectin levels measured via EDTA plasma ELISA assays[T0, T4 and T8 (weeks)];Changes in leptin levels measured via EDTA plasma ELISA assays[T0, T4 and T8 (weeks)]

Secondary Outcome Measures

Name	Time	Method
Changes in Pathology results (ELFT, Omega 3 Indices, CRP, HbA1C)[T0, T4 and T8 (weeks)];Changes in anthropometric data (BMI, hip:waist ratio)[T0, T4 and T8 (weeks)];Results from International Physical Activity Questionaire (IPAQ)[T0, T4 and T8 (weeks)];Results from Fatigue Questionaire (FIS)[T0, T4 and T8 (weeks)];Results from Fatigue 3 day unannounced dietary recall[T0, T4 and T8 (weeks)]