Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000402842
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
12/04/2021
Date last updated
7/03/2023
Date data sharing statement initially provided
12/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of optimising amino acid intake on obesity rates in individuals aged 65-80 years.
Scientific title
A randomised controlled trial to evaluate the effect of supplementation of branched-chain amino acids (BCAA) by itself or combined with tryptophan or methionine on appetite in individuals aged 65-80 years.
Secondary ID [1] 303019 0
Nil known
Universal Trial Number (UTN)
U1111-1262-7265
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 320083 0
Condition category
Condition code
Diet and Nutrition 318013 318013 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with ad libitum access to a standard diet containing 18-19% of energy as protein, 30-35% fat and up to 45-65% carbohydrate as per the Acceptable Macronutrient Distribution Ranges set by the NHMRC. A bottle of 1L of olive oil will be provided to participants to be used as salad dressing. Study diets will be provided via a meal delivery company (Kinela). Milk (up to 100mL a day), fresh fruit (up two serves of fruit a day) and vegetables (up to two cups of salad a day) will also be allowed as additions to the diet provided and a list of approved additions and quantities will be provided. Those randomised to BCAA, BCAA+tryptophan and BCAA+methionine will be provided with supplements to be consumed in conjunction with their meals. All foods and supplements consumed will be recorded in the study food diary to be kept by each participant.

Participants in the BCAA group will be provided with a sealed bottle containing 100 capsules of Solgar, BCAA Plus, Free Form Capsules which contains 540mg of L-leucine, 360mg of L-isoleucine and 300mg of L-valine each. Participants will be asked to consume one capsule, three times daily of this supplement along with their food (i.e. breakfast, lunch and dinner) for 4 weeks.

Participants in the BCAA + tryptophan group will be provided with a sealed bottle containing 60 capsules of Now Foods L-Tryptophan, Double Strength which contains 1000 mg of L-tryptophan each and a sealed bottle containing 100 capsules of Solgar, BCAA Plus, Free Form Capsules which contains 540mg of L-leucine, 360mg of L-isoleucine and 300mg of L-valine each. Participants will be asked to consume one capsule, twice daily of the tryptophan supplement along with their main meals (i.e. lunch or dinner) and one capsule, three times daily of BCAA supplement along with their food (i.e. breakfast, lunch and dinner) for 4 weeks.

Participants in the BCAA + methionine group will be provided with a sealed bottle containing 100 capsules of Now Foods L-Methionine which contains 500 mg of L-methionine each and a sealed bottle containing 100 capsules of Solgar, BCAA Plus, Free Form Capsules which contains 540mg of L-leucine, 360mg of L-isoleucine and 300mg of L-valine each. Participants will be asked to consume one capsule, three times daily of methionine and BCAA supplements along with their food (i.e. breakfast, lunch and dinner) for 4 weeks.
Intervention code [1] 319307 0
Prevention
Comparator / control treatment
Participants will be provided with ad libitum access to a standard diet containing 18-19% of energy as protein, 30-35% fat and up to 45-65% carbohydrate as per the Acceptable Macronutrient Distribution Ranges set by the NHMRC. A bottle of 1L of olive oil will be provided to participants to be used as salad dressing. Study diets will be provided via a meal delivery company (Kinela). Milk (up to 100mL a day), fresh fruit (up two serves of fruit a day) and vegetables (up to two cups of salad a day) will also be allowed as additions to the diet provided and a list of approved additions and quantities will be provided. Those randomised to the control group will be provided with the same diet as the intervention group to be consumed ad libitum, with no additional supplements.
Control group
Active

Outcomes
Primary outcome [1] 326009 0
Objective/quantitative appetite assessed by plasma FGF21 and grehlin.
Timepoint [1] 326009 0
Baseline and four-week post intervention commencement.
Primary outcome [2] 326641 0
Subjective/qualitative appetite assessed by participant self-report (assessed by appetite questionnaire).
Timepoint [2] 326641 0
Baseline and four-week post intervention commencement.
Primary outcome [3] 327114 0
Subjective/qualitative energy intake assessed by participant self-report (weighed food record)
Timepoint [3] 327114 0
Baseline and four-week post intervention commencement.
Secondary outcome [1] 390921 0
Body composition: Body composition will be measured via the BodPod and the following measures will be obtained: body mass, body fat mass, body fat free mass.
Timepoint [1] 390921 0
Baseline and four-week post intervention commencement.
Secondary outcome [2] 390922 0
Blood pressure: Three systolic and diastolic blood pressure measurement using a sphygmomanometer will be taken 1 minute apart after 5 minutes of quiet rest in a seated position.
Timepoint [2] 390922 0
Baseline and four-week post intervention commencement.
Secondary outcome [3] 391028 0
Stool samples will be used for measurement of the gut microbiome.
Timepoint [3] 391028 0
Baseline and four-week post intervention commencement.
Secondary outcome [4] 391029 0
Grip strength assessed using a hand dynamometer.
Timepoint [4] 391029 0
Baseline and four-week follow-up
Secondary outcome [5] 391030 0
Serum biochemistry including EUC, calcium, phosphate, protein, albumin, amino acids, triglycerides, total cholesterol, HDL cholesterol, glucose, insulin, CRP, IGF-1, leptin and liver function (ALT, AST and LD) will be measured as markers of cardio-metabolic health.
Timepoint [5] 391030 0
Baseline and four-week post intervention commencement.
Secondary outcome [6] 392261 0
Waist and hip circumference will be measured using a measuring tape made of fiberglass.
Timepoint [6] 392261 0
Baseline and four-week post intervention commencement.
Secondary outcome [7] 392262 0
Lower limb strength assessed using number of repeated chair stands in 30 seconds.
Timepoint [7] 392262 0
Baseline and four-week post intervention commencement.
Secondary outcome [8] 392263 0
Six-meter walk speed will be measured to assess functional status and overall health.
Timepoint [8] 392263 0
Baseline and four-week post intervention commencement.
Secondary outcome [9] 392264 0
Peripheral blood mononuclear cells (PBMC) for cytokine analysis will be measured as a marker of inflammation.
Timepoint [9] 392264 0
Baseline and four-week post intervention commencement.
Secondary outcome [10] 393851 0
Short chain fatty acids will be measured in serum as marker of inflammation.
Timepoint [10] 393851 0
Baseline and four-week post intervention commencement.

Eligibility
Key inclusion criteria
Females (post-menopausal) or males, 65-80 years, BMI 20-35kg/m2 will be recruited
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include diabetes mellitus (insulin dependent, Type 1 or 2), renal or liver disease, cancer or active neoplasms, hyperthyroidism (unless treated or under control), schizophrenia, sleep apnea, taking medications known to affect weight or energy expenditure, antibiotics use in the previous four weeks, unintentional weight loss (>10% body weight) over the past 5 years, smoking, alcohol intake >3 standard drinks/day or unwilling to refrain from alcohol, vegan and vegetarians, food allergies and/or intolerances, and when changes in diet are contraindicated by treating doctor.

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 will be concealed (sealed opaque numbered envelopes). Participants randomised to intervention group will be blinded to which intervention they are receiving, whereas those on the control group will know they are in the control group. The study coordinators will not be blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Males and females will be randomized to each intervention using permuted block randomisation. Random blocks of 4 will be generated using the R package “blockrand” for males and females separately.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of measures collected at baseline and final testing will be performed using linear mixed model regression with and without covariates to test the effect of the 4 different diet interventions. Linear regression and/or general additive model in R will be used to test the relationship between habitual dietary intakes and baseline measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2022
Actual
10/05/2022
Date of last participant enrolment
Anticipated
1/11/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
110
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307430 0
Charities/Societies/Foundations
Name [1] 307430 0
Phillip Bushnell foundation
Country [1] 307430 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 308101 0
None
Name [1] 308101 0
Address [1] 308101 0
Country [1] 308101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307512 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 307512 0
Ethics committee country [1] 307512 0
Australia
Date submitted for ethics approval [1] 307512 0
30/11/2020
Approval date [1] 307512 0
09/12/2020
Ethics approval number [1] 307512 0
2020/ETH02622

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

Contacts
Principal investigator
Name 107502 0
Dr Rosilene Ventura Ribeiro
Address 107502 0
Building D17, Level 4 East 47, The University of Sydney, Camperdown NSW, 2006
Country 107502 0
Australia
Phone 107502 0
+610286270778
Fax 107502 0
Email 107502 0
[email protected]
Contact person for public queries
Name 107503 0
Rosilene Ventura Ribeiro
Address 107503 0
Building D17, Level 4 East 47, The University of Sydney, Camperdown NSW, 2006
Country 107503 0
Australia
Phone 107503 0
+610286270778
Fax 107503 0
Email 107503 0
[email protected]
Contact person for scientific queries
Name 107504 0
Stephen Simpson
Address 107504 0
D17 - Charles Perkins Centre Research and Education Hub, The University of Sydney, Camperdown NSW, 2006
Country 107504 0
Australia
Phone 107504 0
+61 2 86271613
Fax 107504 0
Email 107504 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not intend to share participants data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10351Ethical approval  [email protected] 381111-(Uploaded-27-01-2021-12-38-44)-Study-related document.pdf



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.