Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001528448
Ethics application status
Approved
Date submitted
9/05/2016
Date registered
7/11/2016
Date last updated
7/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short term effects of supplementing the amino acid, leucine during weight loss on improvements in body composition and insulin sensitivity in individuals at risk of the metabolic syndrome.
Scientific title
A pilot trial on the short term effects of leucine supplementation during weight loss, on body composition, insulin sensitivity and metabolic flexibility in the metabolic syndrome.
Secondary ID [1] 285407 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 293154 0
Insulin resistance 293156 0
metabolic syndrome 300049 0
cardio vascular 300050 0
Condition category
Condition code
Diet and Nutrition 293423 293423 0 0
Obesity
Metabolic and Endocrine 293424 293424 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blinded, randomized controlled trial. All subjects will be prescribed individualized diets. Energy requirements will assessed at baseline by measuring resting metabolic rate and using an activity factor of 1.5 for men/ 1.3 for women. Subjects will be prescribed 75% of their estimated energy requirements. Dietary composition will follow NHMRC dietary guidelines except for dairy products which will be restricted to 1 serve per day and meat intake that will prescribed at no more than 3 serves/week for men and 2 serves/ week for women. Participants will be provided with the two weeks menu with recipe cards so they can prepare their own meals at home.

Study duration: 8-week program.
Study diets: All diets are restricted in energy intake. Daily Diet composition will be 65% carbohydrate, 20% protein, 15% Fat
Control group: Control diet plus placebo (lactose) oral capsules (~3 grams/day)
Experimental group: Control diet plus leucine oral capsules(~3 grams/day)
Both placebo and leucine capsules made up by Pharmacy 777.

Each participant will be called for fortnightly visits to check their diet and capsule compliance. Diet Compliance will be checked in oral discussion and any issues will be sorted. Capsule compliance will be done by checking self reported capsule fill-in form. At the end of trial all will be asked to fill in food questionaire which can be compared with the prescribed intake. Capsule count will be done at each 4 weeks when they return empty container and self reported form.
Intervention code [1] 290327 0
Lifestyle
Intervention code [2] 295741 0
Treatment: Other
Comparator / control treatment
Placebo: Lactose 3g/d
Control group
Placebo

Outcomes
Primary outcome [1] 293249 0
Body composition by Dual Energy X-ray Absorptiometry (DEXA, Prodigy, Lunar)
Timepoint [1] 293249 0
8 weeks post commencement of supplementation
Primary outcome [2] 300041 0
insulin sensitivity from fasting blood samples and measures of glucose, insulin and triglycerides to calculate surrogate markers like HOMA-IR, McAuleys' index, ISI.
Timepoint [2] 300041 0
8 weeks post commencement of supplementation
Secondary outcome [1] 310667 0
substrate oxidation by indirect calorimetry
Timepoint [1] 310667 0
8 weeks post commencement of supplementation
Secondary outcome [2] 327266 0
Liver function tests from fasting blood samples and measures of Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase and total and conjugated bilirubin concentrations,
Timepoint [2] 327266 0
8 weeks post commencement of supplementation
Secondary outcome [3] 327267 0
vitamin D status from Serum 25 hydroxycholecalciferol (25OHD) levels
Timepoint [3] 327267 0
8 weeks post commencement of supplementation

Eligibility
Key inclusion criteria
Adult Australian men and women with abdominal obesity and at least one other criteria for MetS as judged by recent consensus guidelines (Alberti et al, 2009), aged 20- 65 years, of European origin, Not on calcium or vitamin supplements. Medications like lipid lowering therapy and hypertension will be quantified and monitored.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
any history of MI, stroke, T1DM or weight loss in previous 6 months,on medication that affects body composition, energy expenditure or food intake will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers with identical shape, colour and size of capsules.
Participants will be allocated to treatment by a third person who is not involved in either data collection or data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be done using computerised software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: ANOVA for repeated measures (2 time points), with treatment effect (2 diets) and interaction, to detect a small effect size of 0.25, a = 0.05, power = 80% and 0.5 correlation between measures, we needed a sample of N= 34 i.e. 17 per diet group.

Repeated measures ANOVA and ANCOVA of post-treatment values adjusted for pre-treatment values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/08/2013
Date of last participant enrolment
Anticipated
Actual
4/05/2014
Date of last data collection
Anticipated
Actual
4/07/2014
Sample size
Target
34
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290013 0
University
Name [1] 290013 0
Curtin University
Country [1] 290013 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Mario Soares
Address
School Of Public Health,
Faculty of health Sciences, Curtin University
Kent Street, Bentley, Perth, Western Australia 6102.

Country
Australia
Secondary sponsor category [1] 293266 0
None
Name [1] 293266 0
Address [1] 293266 0
Country [1] 293266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291721 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291721 0
CURTIN UNIVERSITY
Kent Street, Bentley Campus, Perth, Western Australia 6102.

Ethics committee country [1] 291721 0
Australia
Date submitted for ethics approval [1] 291721 0
Approval date [1] 291721 0
16/07/2013
Ethics approval number [1] 291721 0
4493/13

Summary
Brief summary
This is a pilot trial of 8 weeks duration examining whether additional supplementation of leucine (3 grams/day) during calorie restriction is better than weight loss alone in reducing fat loss and muscle loss.
The hypothesis is that leucine will improve muscle mass retention and increase fat loss, hence improving insulin action. We envisage an improved body composition that will favour those at risk of metabolic syndrome to reduce their risk of type 2 diabetes and cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51738 0
A/Prof Mario Soares
Address 51738 0
School of Public Health
Curtin University
Bentley Campus
Perth, Western Australia 6102
Country 51738 0
Australia
Phone 51738 0
+61,8,92663220
Fax 51738 0
+61,8,92662958
Email 51738 0
m.soares@curtin.edu.au
Contact person for public queries
Name 51739 0
A/Prof Mario Soares
Address 51739 0
School of Public Health
Curtin University
Bentley Campus
Perth, Western Australia 6102
Country 51739 0
Australia
Phone 51739 0
+61,8,92663220
Fax 51739 0
+61,8,92662958
Email 51739 0
m.soares@curtin.edu.au
Contact person for scientific queries
Name 51740 0
A/Prof Mario Soares
Address 51740 0
School of Public Health
Curtin University
Bentley Campus
Perth, Western Australia 6102
Country 51740 0
Australia
Phone 51740 0
+61,8,92663266
Fax 51740 0
Email 51740 0
m.soares@curtin.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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