Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000419460
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
7/05/2025
Date last updated
7/05/2025
Date data sharing statement initially provided
7/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a high-fat diet in overweight or obese young males, with or without branched-chain amino acids supplementation.
Scientific title
A randomized controlled study of effects of branched-chain amino acids supplementation to a high-fat diet in overweight or obese young males
Secondary ID [1] 313555 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 336057 0
Insulin resistance 336058 0
obesity 336059 0
Condition category
Condition code
Diet and Nutrition 332612 332612 0 0
Other diet and nutrition disorders
Diet and Nutrition 332611 332611 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The high-fat diet consisted of 30% carbohydrates, 20% protein, and 50% fat, with fat comprising 1:1:1 monounsaturated, polyunsaturated, and saturated fat.
For the high-fat diet plus branched-chain amino acids (BCAA), we added 0.1/kg/day of branched-chain amino acids to the participant’s high-fat diet. We used Dymatize’s BCAA Complex 2200 capsules in the BCAA group; each capsule contains leucine 275mg, isoleucine 137.5mg and valine 137.5mg. Capsule count was performed at the end of the 14-day intervention. The participants were randomized into the diet groups, and the metabolic kitchen provided three meals per day. The participants ate breakfast at the investigational unit and brought the remaining two meals home. The meals were prepared as ready-to-go. Participants were required to take a photograph of the food taken each day and to log any additional food. To increase compliance, the menu consisted of locally available and commonly consumed foods that most subjects could identify with. The controlled feeding protocol was implemented and strictly monitored by the dietitian. The intervention period was 14 days.
Intervention code [1] 330440 0
Lifestyle
Comparator / control treatment
The usual mixed diet was high carbohydrate. It consisted of 55-60% carbohydrates, 25-30% fat, and 10-15% protein. As alluded to above, the dietitian administered the dietary protocol, and the metabolic kitchen prepared food for 14 days.
Control group
Active

Outcomes
Primary outcome [1] 340563 0
body weight
Timepoint [1] 340563 0
at baseline and end of dietary intervention
Primary outcome [2] 340127 0
insulin sensitivity
Timepoint [2] 340127 0
baseline and at the end of the diet intervention
Secondary outcome [1] 446522 0
phosphorylated mTOR in response to different insulin concentrations in skeletal muscle explants
Timepoint [1] 446522 0
at baseline and at the end of dietary intervention
Secondary outcome [2] 444475 0
plasma ceramides
Timepoint [2] 444475 0
baseline and at the end of intervention
Secondary outcome [3] 444476 0
urinary organic acids
Timepoint [3] 444476 0
baseline and at the end of dietary intervention
Secondary outcome [4] 444477 0
protein expression of mTOR
Timepoint [4] 444477 0
baseline and at the end of dietary intervention
Secondary outcome [5] 444474 0
plasma acylcarnitines
Timepoint [5] 444474 0
baseline and at the end of dietary intervention
Secondary outcome [6] 446521 0
phosphorylated AKT in response to different insulin concentrations in skeletal muscle explants
Timepoint [6] 446521 0
at baseline and at the end of dietary intervention
Secondary outcome [7] 442855 0
Changes in plasma branched-chain amino acids
Timepoint [7] 442855 0
baseline and at the end of the dietary intervention
Secondary outcome [8] 442856 0
phosphorylated IRS in response to different insulin concentrations in skeletal muscle explants
Timepoint [8] 442856 0
at baseline and at the end of dietary intervention

Eligibility
Key inclusion criteria
21-40 years males, body mass index between 23 to 30 kg/m2 with normal glucose tolerance as confirmed by the 75-gm oral glucose tolerance test.
Minimum age
21 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
known history of diabetes mellitus, known history of malignancy, were on medications that will likely affect glucose metabolism (e.g. corticosteroids) or lipid metabolism/insulin resistance (e.g. niacin, fibrates, PPAR-y agonist, metformin), current smoking, daily alcohol consumption, weight gain or loss of more than 5% over the past three months, unusual diet practice (i.e. high protein intake, vegetarians) or high level of physical activity (exercise >5hr per week). All participants were required to cease smoking and alcohol intake before procedures and throughout the study duration.

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)
The randomization was conducted using an equal group random allocation method by the dietitian. We used number containers to maintain allocation concealment and generate a randomization list to determine which diet group corresponds to each container number. This list is kept and assessable only by the dietitian. Even though dietitian was part of the study team, the allocation was concealed to the investigator and other study teams. The randomization was blinded to the investigators and research staff who conducted all the outcome measurements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was conducted using an equal group random allocation method
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses were performed using SPSS 26.0 software (SPSS, Inc., Chicago, IL). All values are given as means ± SD unless stated otherwise. P<0.05 was considered as statistically significant. An analysis of variance with Bonferroni correction was used to test the pairwise comparison for the anthropometric and metabolic parameter changes between the three diet groups. A paired t-test was used to test the significance of the mean difference for each metabolite (amino acids, acylcarnitines, organic acids and ceramide species) pre-post dietary intervention for each diet group. The areas under the MMTT curve (AUC) were calculated using the trapezoidal method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
15/01/2015
Date of last data collection
Anticipated
Actual
12/02/2015
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 26776 0
Singapore
State/province [1] 26776 0

Funding & Sponsors
Funding source category [1] 318019 0
Government body
Name [1] 318019 0
National Medical Research Council
Country [1] 318019 0
Singapore
Primary sponsor type
Government body
Name
National Medical Research Council
Address
Country
Singapore
Secondary sponsor category [1] 320361 0
None
Name [1] 320361 0
Address [1] 320361 0
Country [1] 320361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316677 0
The NHG Domain Specific Review Board
Ethics committee address [1] 316677 0
Ethics committee country [1] 316677 0
Singapore
Date submitted for ethics approval [1] 316677 0
01/02/2012
Approval date [1] 316677 0
06/03/2012
Ethics approval number [1] 316677 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138630 0
Dr Chin Meng Khoo
Address 138630 0
National University Hospital, 5 Lower Kent Ridge Road, Singapore 119074
Country 138630 0
Singapore
Phone 138630 0
+6597249456
Fax 138630 0
Email 138630 0
[email protected]
Contact person for public queries
Name 138631 0
Chin Meng Khoo
Address 138631 0
National University Hospital, 5 Lower Kent Ridge Road, Singapore 119074
Country 138631 0
Singapore
Phone 138631 0
+6597249456
Fax 138631 0
Email 138631 0
[email protected]
Contact person for scientific queries
Name 138632 0
Chin Meng Khoo
Address 138632 0
National University Hospital, 5 Lower Kent Ridge Road, Singapore 119074
Country 138632 0
Singapore
Phone 138632 0
+6597249456
Fax 138632 0
Email 138632 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: only upon request



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.