Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001056381
Ethics application status
Approved
Date submitted
28/06/2017
Date registered
19/07/2017
Date last updated
20/02/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of fish oil supplementation and resistance exercise on inflammation in healthy post-menopausal women
Scientific title
The effects of acute post-exercise biochemical milieu of older women following fish oil supplementation and satellite cell cycling
Secondary ID [1] 292295 0
None
Universal Trial Number (UTN)
Trial acronym
PSS (PUFA Serum Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 303824 0
Sarcopenia 303825 0
Condition category
Condition code
Metabolic and Endocrine 303199 303199 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 303200 303200 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All Participants will perform a light session of resistance-based exercise following a thorough warm up. The session of resistance-based exercise consists of machine-based exercises (described below) that provide a supporting surface for balance when performing the exercise. All participants will also undertake pre-testing and measures of body composition one week prior to the trial to ensure the amount of weight lifted during the exercise session can be safely and confidently performed.

This study is a randomised cross over trial, meaning that participants will be randomised into two groups. Either group 1 (fish oil) or group 2 (coconut oil/placebo). After a washout period of 4 weeks, participants will swap groups so that at the end of the trial each participant will have completed a period of fish oil supplementation and a period of coconut oil supplementation. Participants will be randomly allocated to one of the following two experimental:
Group 1: Fish Oil supplementation
Participants allocated to this group will be required to consume 4 fish oil capsules (6g/d containing 2.16g of EPA and 1.42g of DHA) PUFA daily for 4 weeks. We recommend that participants space their consumption of the fish oil evenly throughout the day and advise participants to take two fish oil capsules in the morning and two capsules in the evening.

Side effects: The side effects of fish oil supplementation are rare but may include heartburn, nausea, loose stools and rash. Consumption of fish oil supplements can also lead a fishy after taste that may be unpleasant. The fish oil supplement we have chosen for this study is designed to minimise fishy after taste. If you have a known allergy or hypersensitivity to fish or other fish products (including shellfish), you should be not consuming fish oil supplements.

Exercise session
The duration of the exercise session, including adequate warm-ups, will be ~60 minutes. The following exercises have been selected as they are low risk and easy for untrained individuals to complete. The following exercises have been selected based on previous established protocols as they are low risk and the most basic exercises for untrained individuals to complete. The following exercises have been used in previous studies thus deemed safe for older adults to perform.
Acute Resistance Exercise Session:
1. Leg Press - 3x10 @ RPE 7-8
2. Leg Extensions - 2 x 12 @ RPE 7-8
3. Machine Chest Press - 3 x 10 @ RPE 7-8
4. Dumbbell Side Lateral Raises - 3 x 12 @ RPE 7-8

Resistance exercise will take place at the end of the supplementation periods
To monitor adherence to the intervention participants will be asked to return capsules not consumed. Analysis of blood will also determine adherence to the intervention
Intervention code [1] 298471 0
Treatment: Other
Comparator / control treatment
Group 2: Placebo (Coconut Oil)
Participants allocated to this this group will be required to consume 6 coconut oil capsules (6g) daily for 4 weeks. We recommend that participants space their consumption of the coconut oil evenly throughout the day and advise participants to take 3 capsules in the morning and 3 capsules in the evening.

Side effects: There are no known side effects of coconut oil
Control group
Placebo

Outcomes
Primary outcome [1] 302574 0
Change in Inflammatory markers in blood (TNF-a, Il-6, Il-1)
Timepoint [1] 302574 0
After Fish Oil supplementation (at the end of 4 week intervention period).
Samples will be collected before and after the exercise sessions.
Secondary outcome [1] 336419 0
in-vitro analysis of muscle cell activation.

Serum will be isolated from the blood of participants and used to investigate its effect on muscle cell growth
Timepoint [1] 336419 0
Serum taken collected from participants before supplementation, after supplementation and after exercise with supplementation will be used to grow muscle cells in-vitro to investigate their effects on muscle cell growth.

Eligibility
Key inclusion criteria
i) Female aged 50-65 yo
ii) Are currently Post-Menopausal (no periods for 12 and over consecutive months)
iii) Have a Body Mass Index (BMI) of 18.5-29
iv) Not exercising more than 3 times per week
v) Not currently taking any blood thinning medication e.g. (Warfarin, Aspirin or Dabigatran), anti-inflammatory medication or supplements (anti-allergenic) and not taking fish oil supplements
vi) Do not have any known allergies to fish products or coconut oil
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoker
Currently taking taking any blood thinning medication e.g. (Warfarin, Aspirin or Dabigatran), anti-inflammatory medication or supplements (anti-allergenic) and taking fish oil supplements
Type 2 diabetes

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
4 week washout period between groups
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2017
Actual
20/09/2017
Date of last participant enrolment
Anticipated
20/04/2018
Actual
30/04/2018
Date of last data collection
Anticipated
20/04/2018
Actual
14/08/2018
Sample size
Target
12
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296839 0
University
Name [1] 296839 0
Australian Catholic University
Country [1] 296839 0
Australia
Primary sponsor type
Individual
Name
Bill Tachtsis
Address
Mary MacKillop Institute for Health Research
115 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 295840 0
None
Name [1] 295840 0
Address [1] 295840 0
Country [1] 295840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298071 0
ACU Human Research Ethics Committee
Ethics committee address [1] 298071 0
PO Box 968
North Sydney
NSW 2059
Ethics committee country [1] 298071 0
Australia
Date submitted for ethics approval [1] 298071 0
18/01/2017
Approval date [1] 298071 0
26/04/2017
Ethics approval number [1] 298071 0
2017-10H

Summary
Brief summary
The aims of this project are to:
a. investigate whether the serum composition of post-menopausal women can be altered with 4 weeks of fish oil supplementation and an acute bout of resistance exercise
b. Can changes to inflammatory markers in serum alter the activity of muscle cells grown in-vitro
Proposal research design:
The study is a randomized cross-over design study with a 4 week washout period between groups:
Fish Oil group. Participants will be required to ingest 4 fish oil capsules (6g/d containing 2.16g of EPA and 1.42g of DHA) PUFA daily for 4 weeks. This dose has been selected as it is the dosage range recommended by the Australian Heart Foundation for lowering plasma triglyceride concentrations in hypertriglyceridemic subjects and has therefore previously been shown to be physiologically relevant in human subjects.

Placebo group. Participants will be required to ingest equivalent amounts of coconut oil (6g/d) for 4 weeks. Coconut oil has been selected as it has been used as a control in other studies involving fish oil.

Resistance Exercise. The acute exercise intervention will consist of both upper and lower body exercises including: the leg press, leg extensions, the bench press and dumbbell side lateral raises. The duration of the exercise session, including adequate warm-ups, will be ~60 minutes.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75898 0
Mr Bill Tachtsis
Address 75898 0
Mary MacKillop Institute for Health Research
215 Spring St, Melbourne VIC 3000
Country 75898 0
Australia
Phone 75898 0
+61 431599428
Fax 75898 0
Email 75898 0
[email protected]
Contact person for public queries
Name 75899 0
Bill Tachtsis
Address 75899 0
Mary MacKillop Institute for Health Research
215 Spring St, Melbourne VIC 3000
Country 75899 0
Australia
Phone 75899 0
+61 431599428
Fax 75899 0
Email 75899 0
[email protected]
Contact person for scientific queries
Name 75900 0
Bill Tachtsis
Address 75900 0
Mary MacKillop Institute for Health Research
215 Spring St, Melbourne VIC 3000
Country 75900 0
Australia
Phone 75900 0
+61 431599428
Fax 75900 0
Email 75900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.