UMIN-ICDS Clinical Trial

Public title

The Relationship Between Physical Activity Levels and Protein Requirements using amino acid oxidation methods in Young Adult Males.

Acronym

The Relationship Between Physical Activity Levels and Protein Requirements using amino acid oxidation methods in Young Adult Males.

Scientific Title

The Relationship Between Physical Activity Levels and Protein Requirements using amino acid oxidation methods in Young Adult Males.

Scientific Title:Acronym

The Relationship Between Physical Activity Levels and Protein Requirements using amino acid oxidation methods in Young Adult Males.

Region

Japan

Condition

The Relationship Between Physical Activity Levels and Protein Requirements using amino acid oxidation methods in Young Adult Males.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to elucidate the protein requirements of Japanese individuals, taking into consideration their physical activity levels. Young adult males will be the focus of this investigation, and the total energy expenditure will be measured using the doubly labeled water method, while the protein requirements will be assessed using the indicator amino acid oxidation technique.

Basic objectives2

Others

Basic objectives -Others

Exploration of Factors Related to Protein Requirements.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

protein requirement

Key secondary outcomes

1. Physical activity level and insulin resistance
2. Protein intake (kg/day)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

30

years-old

>=

Gender

Male

Key inclusion criteria

A person capable of obtaining research participation consent through written means from the individual's own free will.

Key exclusion criteria

Individuals with chronic diseases or acute illnesses affecting protein and amino acid metabolism (e.g., diabetes, malignant tumors, liver or kidney diseases, thyroid disorders, etc.).
Individuals consuming more than 0.5g/kg of protein daily.
Individuals using regular medications (e.g., medications for diabetes treatment, alpha-blockers, beta-blockers, or other drugs affecting metabolism).
Individuals with knee or hip conditions causing impairment in daily activities.
Individuals with a history of digestive system surgery (primarily involving the esophagus, stomach, duodenum, small intestine, colon, or liver, except for appendix removal surgery which is permissible).
Individuals with extremely irregular dietary habits.
Individuals currently participating in or expressing intent to participate in trials involving the intake of other food items, medication usage, application of cosmetics or drugs, etc.
Individuals with food allergies to standard meals which is used in the present study.
Individuals with drinking and smoking habits (up to twice a week is acceptable) that cannot be controlled during the study period.
Other individuals deemed unsuitable as subjects by the principal investigator or physician (research collaborator).

Target sample size

30

Name of lead principal investigator

1st name	Yasuki
Middle name
Last name	Higaki

Organization

Fukuoka University

Division name

Faculty of Sports and Health Science

Zip code

814-0180

Address

8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan

TEL

092-871-6631

Email

higaki@fukuoka-u.ac.jp

Name of contact person

1st name	Yoichi
Middle name
Last name	Hatamoto

Organization

National Institute of Health and Nutrition National Institutes of Biomedical Innovation,

Division name

Department of Nutrition and metabolism

Zip code

5660002

Address

3-17 Senrigaokashinmachi, Settsu, Osaka, 566-0002,1-23-1 Toyama, Shinjuku-ku, Tokyo, 162-8636, Japan

TEL

06-6384-1120

Homepage URL

Email

yhatamoto@nibiohn.go.jp

Institute

Fukuoka University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

same as above

Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan

Tel

092-801-1011(3193)

Email

fumed-ethics@fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

06

Month

12

Day

Date of IRB

2023

Year

06

Month

12

Day

Anticipated trial start date

2023

Year

07

Month

20

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The aim of this study is to investigate the relationship between protein requirements and the three categorized levels of physical activity, as defined in the Japanese dietary reference intakes, among young healthy adults. The assessment of physical activity levels and protein requirements will be conducted using two established gold standard methods: the doubly labeled water method (DLW) and the indicator amino acid oxidation method (IAAO), both utilizing stable isotope intake. Initially, a screening survey will be conducted to select eligible participants. Based on the screening results, individuals meeting the criteria will be categorized into the appropriate physical activity levels corresponding to the dietary reference intakes, using data obtained from a triaxial accelerometer to estimate their physical activity levels. Subsequently, to accurately determine the participants' physical activity levels, the total energy expenditure will be quantified using the DLW method, which is considered the most precise method under free-living conditions. After completing the DLW measurements, the IAAO method will be employed. The IAAO method involves a seven-week dietary intervention, wherein participants will consume meals with varying protein content across seven levels. This test will be conducted once a week (one level per day) to assess their amino acid oxidation and derive insights into their protein requirements. For IAAO methods. One participant performs seven conditions with varying protein intake levels (0.1g/kg to 2.0g/kg), each conducted with a washout period of 5-7 days. The test meals with varying protein intake levels (0.1, 0.4, 0.7, 1.0, 1.3, 1.6, 2.0 g/kg) are randomly administered.

Registered date

2023

Year

07

Month

31

Day

Last modified on

2024

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059083