UMIN-CTR Clinical Trial

Basic information
Public title	Effects of branched-chain amino acids supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes: a randomized controlled study
Acronym	BCAA supplementation in elderly patients with type 2 diabetes
Scientific Title	Effects of branched-chain amino acids supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes: a randomized controlled study
Scientific Title:Acronym	BCAA supplementation in elderly patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of branched-chain amino acids (BCAA) supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in skeletal muscle mass after 24-week intervention
Key secondary outcomes	Changes in HbA1c levels, fasting plasma glucose, HOMA-IR, serum levels of total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol, amino acid profiles, tryptophan metabolites, body weight, lean body mass, fat mass, muscle strength (leg extension), grip strength, standing balance ability (index of postural stability, one-leg standing time) and score of Quick Inventory of Depressive Symptomatology

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	BCAA 6g
Interventions/Control_2	Soy protein 7.5g
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with type 2 diabetes. 2. Changes in HbA1c levels over the past six months are less than 1 %.
Key exclusion criteria	1. Patients with diabetes caused by other than type 2 diabetes 2. Insulin treated patients 3. Patients with eGFR <30 ml/min/1.73m2 4. Patients with active preproliferative or proliferative diabetic retinopathy 5. Patients who do not indicate for exercise therapy due to bone and joint disease 6. Patients treated with glucocorticoids or anabolic steroids 7. Patients treated with growth hormone
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Suzuki
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Internal Medicine (Endocrinology and Metabolism)
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Jpanan
TEL	029-853-3053
Email	hirosuzu@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Suzuki
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Internal Medicine (Endocrinology and Metabolism)
Zip code	305-8575
Address	1-1-1, Tennodai, Tsukuba, Ibaraki 305-8575, Jpanan
TEL	029-853-3053
Homepage URL
Email	hirosuzu@md.tsukuba.ac.jp

Sponsor
Institute	Department of Internal Medicine (Endocrinology and Metabolism) Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Honjo International Scholarship Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Graduate School of Agricultural and Life Sciences / Faculty of Agriculture, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsukuba Clinical Research & Development Organization
Address	2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Tel	029-853-3914
Email	rinshokenkyu@un.tsukuba.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 Day

Related information
URL releasing protocol	https://www.mdpi.com/2072-6643/14/19/3917
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2072-6643/14/19/3917
Number of participants that the trial has enrolled	35
Results	Skeletal muscle mass and HbA1c, which were primary endpoints, did not change over time or differ between groups. However, knee extension muscle strength was significantly increased in the soy protein group and showed a tendency to increase in the BCAA group. Homeostasis model assessment for insulin resistance did not significantly change during the trial. Depressive symptoms were significantly improved in the BCAA group but the difference between groups was not significant.
Results date posted	2022 Year 11 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 09 Month 21 Day
Baseline Characteristics	Participants were recruited from persons with type 2 diabetes.
Participant flow	A 24-week, prospective randomized open blinded-endpoint trial was conducted to evaluate the effects of supplementation of 8 g of BCAA or 7.5 g of soy protein on skeletal muscle and glycemic control as well as adverse events in elderly individuals with type 2 diabetes.
Adverse events	The adverse events observed during the intervention period were as follows: sudden cardiac death (n = 1), constipation (n = 2), abdominal discomfort (n = 1), gastric cancer (n = 1), rib fracture (n = 1), prostate cancer (n = 1), colon polyps (n = 1), and heatstroke (n = 1) in the BCAA group and nausea (n = 1), upper respiratory infection (n = 1), rib fracture (n = 1), heatstroke (n = 1), and ureteral stone (n = 1) in the soy protein group. Events other than constipation, abdominal discomfort, and nausea were determined to be unrelated to the intervention.
Outcome measures	The primary outcomes of this study were changes in skeletal muscle mass and HbA1c level. Secondary outcomes included changes in muscle strength (knee extension muscle strength, knee extension muscle endurance, and grip strength), glucose metabolism (fasting plasma glucose [FPG], fasting serum insulin, and HOMA-IR), lipid metabolism (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], and triglycerides [TG]), neuropsychological performance (cognitive function evaluated by Mini Mental State Examination [MMSE]; depression and motivation assessed by the Quick Inventory of Depressive Symptomatology [QIDS] and Starkstein Apathy Scale [SAS], respectively), tryptophan metabolites (kynurenine and kynurenic acid), and renal function (estimated glomerular filtration rate [eGFR] and urinary albumin excretion [UAE]). In the post-hoc analysis, changes in insulin-like growth factor-1 (IGF-1), follistatin, and brain-derived neurotropic factor (BDNF) were evaluated.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 27 Day
Date of IRB	2018 Year 05 Month 11 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2022 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 24 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036175