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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000670572 |
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Date of registration:
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29/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Different Fatty Acids on Metabolic Rate in Overweight Women
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Scientific title:
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Effect of Different Fatty Acids on Metabolic Rate in Overweight Women |
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Date of first enrolment:
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11/06/2015 |
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Target sample size:
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40 |
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Recruitment status: |
Stopped early |
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URL:
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https://anzctr.org.au/ACTRN12615000670572.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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A/Prof Alison Coates
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Address:
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Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Australia |
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Telephone:
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+ 61 8 8302 2313 |
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Email:
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alison.coates@unisa.edu.au |
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Affiliation:
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Name:
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A/Prof Alison Coates
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Address:
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Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Australia |
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Telephone:
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+ 61 8 8302 2313 |
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Email:
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alison.coates@unisa.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Female
2. BMI between 25-35 kg/m2
3. Non-smoker (minimum 6 months of abstinence)
4. Weight stable (changes < 5kg) within the last 3 months
Exclusion criteria: 1. Current smokers and ex-smokers within the last 6 months
2. Consume >1g fish oil supplement/day within the last 3 months
3. Have undergone anticoagulant therapy in the past 3 months
4. Are taking other anti-platelet agents; bleeding disorders
5. Have a cardiac condition (including high blood pressure), asthma, thyroid disorders, chronic disease
6. Have changed medication in the last 3 months
7. Take vitamin, mineral or herbal supplementation that may impact on study outcomes
8. Consume >4 cups coffee/day or a high level of caffeine that in the opinion of the investigators will be unsuitable for this study
9. Suffer claustrophobia or a fear of enclosed spaces
10. Have gained or lost weight (> 5kg) within the last 3 months
11. Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study
12. Are pregnant or breastfeeding (due to changes in metabolic rate)
13. Are allergic to fish or fish products
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Overweight/obesity;
Overweight/obesity
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Diet and Nutrition - Obesity
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Intervention(s)
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A double-blind, randomised, placebo-controlled intervention trial designed to evaluate whether fish oil supplementation can positively impact on metabolic rate in overweight women. Forty volunteers will be recruited through public advertisements. Prior to the commencement of the study volunteers will complete a series of questionnaires and tests designed to assess general health, diet history and exercise habits. Participants will be randomly allocated to consume 5 x 1g capsules per day containing either vegetable oil (control group) or fish oil for the duration of the study. Participants in the control group will receive 5 x 1g capsules of vegetable oil. For participants randomised to the fish oil group, the amount of fish oil provided will be based on participants’ total body weight. Participants will receive 2-5 fish oil capsules (each capsule of fish oil contains 600mg of long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) with the remainder as vegetable oil, providing a total of 5 capsules per day. Possible combinations are therefore; Group 1: up to 65kg (BMI 25-27.5) --> 2 fish oil, 3 placebo, Group 2: 65.1-75kg (BMI 27.6-30) --> 3 fish oil, 2 placebo, Group 3: 75.1-85 (BMI 30.1-32.5) --> 4 fish oil, 1 placebo, Group 4: 85kg and over (BMI 32.6-35) --> 5 fish oil, no placebo. A supplement diary will be used to assess compliance. Participants will attend two study visits at baseline (week 0) and at completion of the intervention (week 6). During these visits each participant will have a series of non-invasive measurements taken which include height, weight, resting energy expenditure, fat oxidation and body fat. Blood samples will be collected at both visits and assessed for erythrocyte saturation of two key fatty acids, DHA and EPA
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Primary Outcome(s)
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Body composition assessed using a Tanita scale[Baseline (week 0) and 6 weeks]
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Resting energy expenditure, measured using an indirect calorimeter[Baseline (week 0) and 6 weeks]
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Fat oxidation, measured using an indirect calorimeter[Baseline (week 0) and 6 weeks]
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Secondary Outcome(s)
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Incorporation of omega-3 (DHA and EPA i.e. the omega-3 Index) into erythrocytes will also be assessed via blood samples collected from participants[Baseline (week 0) and 6 weeks]
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Source(s) of Monetary Support
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EPAX
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University of South Australia
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Ethics review
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Status: Approved
Approval date:
Contact:
University of South Australia Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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