UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050740 |
|---|---|
| Receipt number | R000057813 |
| Scientific Title | The Effects of a dietary supplement containing essential amino acids on exercise-induced fatigue, skeletal muscle mass and muscular strength. |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/09/29 09:20:03 |
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Basic information
Public title
The Effects of a dietary supplement containing essential amino acids on exercise-induced fatigue, skeletal muscle mass and muscular strength.
Acronym
The Effects of a dietary supplement containing essential amino acids on exercise-induced fatigue, skeletal muscle mass and muscular strength.
Scientific Title
The Effects of a dietary supplement containing essential amino acids on exercise-induced fatigue, skeletal muscle mass and muscular strength.
Scientific Title:Acronym
The Effects of a dietary supplement containing essential amino acids on exercise-induced fatigue, skeletal muscle mass and muscular strength.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of 10-week continuous ingestion of supplement containing essential amino acids on exercise-induced fatigue, skeletal muscle mass and muscular strength in generally healthy adults with exercise habit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delayed onset muscle pain
Subjective fatigue
Key secondary outcomes
Muscle strength and endurance
Body composition, body mass, body mass index
Urinary nitrogen
Dietary intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 3 packets in total of the test food (essential amino acids containing supplement) each one packet in the morning, in the afternoon, and 30~60 min after their resistance training daily for 10 weeks.
Interventions/Control_2
Ingest 3 packets in total of the placebo food (substitute essential amino acids with dextrin) each one packet in the morning, in the afternoon, and 30~60 min after their resistance training daily for 10 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 18 years old or more and under 64 years old
3. BMI of 18.5 kg/m2 or more at the time of informed consent
4. Self-reports participating in resistance training 0.5 to 3 times per week for at least a month prior to the start of intervention.
5. Willing to maintain habitual dietary, lifestyle, and physical activity throughout the study.
6. Willing to refrain from exclusionary medications, supplements, and products throughout the study.
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history.
2.Hypertension.
3.History or current diagnosis of amino acid metabolism diseases including, but not limited to, Argininosuccinic acidemia, citrullinemia, homocystinuria, maple syrup urine disease, phenylketonuria, and Tyrosinemia type I.
4.Smoker.
5.Experienced pain in chest at rest, during daily activities of living, or when doing physical activity in the last 12 months.
6.Experienced loss of balance because of dizziness or loss of consciousness in the last 12 months.
7.History or presence of a bone, joint, or soft tissue problem that could be made worse by becoming more physically active in the past 12 months.
8.Advised by medical doctor to only perform medically supervised physical activity in the last 12 months.
9.Any known food allergy as well as intolerance or sensitivity to study product ingredients
10.History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
11.Major trauma or any other surgical event in the past 90 days.
12.Weight loss or gain >4.5 kg in the past 90 days.
13.Extreme dietary habits or a diagnosed eating disorder.
14.Currently or planning to be on a weight loss regimen during the study.
15.Weight loss medications in the past 90 days.
16.Supplements providing amino acids in the past 30 days.
17.Dietary supplements, or products that are known to affect weight loss, appetite, and satiety in the past 30 days.
18.Female who is pregnant, planning to be pregnant during the study period.
19.Recent history of alcohol or substance abuse in the past 12 months.
20.Persons judged as inappropriate for study participant by the principal investigator
21.Persons who have participated in other tests in the past 1 month, or those who intend to participate in another exam after consenting to the exam.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Nagayama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Nagayama.chihiro@hc-sys.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Nagayama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
nagayama.chihiro@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Access Business Group, LLC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
55
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057813
