UMIN-ICDS Clinical Trial

Public title

Studying how daily changes, what you eat or drink, and exercise impact the measurement of body composition using a bioelectrical impedance analysis device

Acronym

The daily changes in the measurements of body composition, and the impact of eating, drinking, and exercise on results

Scientific Title

The day-to-day variation and the effects of water or food consumption and exercise in the assessment of body composition by multifrequency bioelectrical impedance analysis

Scientific Title:Acronym

The day-to-day variation and the effects of drinking, eating, and exercise in the body composition analysis by BIA

Region

Japan

Condition

The research is tailored for the demographic of youthful, healthy individuals (aged 18-29 years). Ultimately, its application is anticipated in populations afflicted with conditions necessitating restricted physical exertion, such as cardiac, cerebrovascular, and orthopedic ailments. Similarly, the application of this study is envisioned for patients with disuse syndrome. Furthermore, it is projected to be relevant for elderly community dwellers participating in specific health checkups and analogous medical evaluations. Additionally, the potential use of results for long-term care service users is also under consideration.

Classification by specialty

Medicine in general	Cardiology	Pneumology
Endocrinology and Metabolism	Nephrology	Neurology
Geriatrics	Surgery in general	Orthopedics
Neurosurgery	Cardiovascular surgery	Laboratory medicine
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this investigation is to ascertain the minimal detectable change(MDC) in the day-to-day fluctuation of outcomes derived from the analysis of body composition via multifrequency bioelectrical impedance analysis. Additionally, the study seeks to elucidate the impact of immediate pre-measurement water and food consumption, and exercise, on the recorded metrics, and to establish MDC in these influences.
We hypothesize that the alterations in the measurements influenced by water, dietary intake, and exercise will be less pronounced than MDC in the daily fluctuation of the obtained body composition analysis results.

Basic objectives2

Others

Basic objectives -Others

Validation of a method for unifying measurement conditions in existing body composition analysis methods.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

The primary outcome measures were skeletal muscle mass and body fat mass, obtained through multifrequency bioelectrical impedance analysis. Measurements were taken on each of the three experimental days at six-time points: immediately after the laboratory visit, post-experimental task (including water or food intake, or exercise), and at 30, 60, 90, and 120 minutes after the completion of the experimental task.

Key secondary outcomes

Secondary outcomes encompass other body composition parameters such as body water content, mineral content, and protein content, as well as electrical resistance metrics including impedance, resistance, and phase angle, all obtained via multifrequency bioelectrical impedance analysis. Measurements will be conducted following the protocol outlined for the primary outcome. Additionally, age and gender will be recorded as general characteristics, and height and weight will be measured. Height will be assessed immediately after each experimental visit on all three experimental days, while weight will be measured in alignment with the primary outcome measurements.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food	Device,equipment	Other

Interventions/Control_1

The intervention for this study consists of experimental tasks involving water or food intake and exercise, which are conducted immediately preceding the body composition analysis using Multifrequency Bioelectrical Impedance Analysis.
All three tasks will be performed on all subjects. Each experimental task will be conducted on three separate days, with a 2 to 7-day interval between each session. The order of the tasks will be randomly assigned to each subject.

First, baseline body composition will be measured. Upon arrival at the laboratory, subjects will be instructed to voidance. Following this, their height and weight will be measured. Subsequently, the subjects will be positioned in a supine posture on the bed for a period of 10 minutes, and the attachments of the body composition analyzer will be placed on the thumb and middle fingers of both hands, as well as on the heels of both sides of the body. Body composition analysis will be conducted immediately after the rest period.

For the water intake task, subjects will consume 200 ml of water directly after the baseline measurement. Their body weight will be immediately measured, followed by another round of anthropometric analysis. Subsequently, body composition analysis will be repeated at 30-minute intervals for a total duration of 120 minutes. Between each measurement, subjects will be instructed to defecate, weigh themselves, and rest for 10 minutes.

During the food intake task, subjects will consume BASE BREAD (registered trademark) immediately after the baseline measurement. The subsequent steps will mirror those of the water intake task.

In the exercise task, subjects will pedal on the ergometer for 15 minutes immediately after the baseline measurement. The exercise intensity will be set to a moderate level, calculated by the formula: exercise heart rate = {(220 - age) - resting heart rate} * 0.4-0.59 + resting heart rate. The remaining procedures will be identical to those of the other tasks.

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

18

years-old

<=

Age-upper limit

29

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Young adults aged 18 to 29 years, in good health.
2. Without any orthopedic, medical, or neurological impairments that could affect their daily activities.
3. Without any cognitive impairments.
4. Independent daily living without the use of walking aids.

Key exclusion criteria

1. Individuals with a pacemaker.
2. Patients with intravital metal or silicon implants.
3. Patients with poorly controlled circulatory problems despite medication or other treatments.
4. Those experiencing orthopedic problems resulting in regular physical pain.
5. Patients with preexisting neurological diseases.
6. Individuals experiencing joint pain in the lower limbs during exercise.
7. Pregnant individuals or those who may be pregnant.
8. Those with known food allergies to any substance to be ingested.
9. Individuals otherwise deemed unsuitable as subjects by the principal investigator.

Target sample size

40

Name of lead principal investigator

1st name	Kimito
Middle name
Last name	Momose

Organization

Shinshu University

Division name

Department of Physical Therapy, School of Health Sciences

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto City, Nagano Prefecture

TEL

0263-37-3453

Email

kmomose@shinshu-u.ac.jp

Name of contact person

1st name	Kio
Middle name
Last name	Fukushima

Organization

Shinshu University

Division name

Graduate School of Medicine, Science and Technology, Department of Health Science

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto City, Nagano Prefecture

TEL

090-1218-1472

Homepage URL

Email

20hm202k@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Kio Fukushima

Organization

Shinshu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shinshu University

Address

3-1-1 Asahi, Matsumoto City, Nagano Prefecture

Tel

0263-37-2572

Email

md_rinri@shinshu-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

信州大学医学部保健学科

Date of disclosure of the study information

2023

Year

10

Month

16

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

03

Month

08

Day

Date of IRB

2023

Year

03

Month

08

Day

Anticipated trial start date

2023

Year

07

Month

11

Day

Last follow-up date

2028

Year

03

Month

08

Day

Date of closure to data entry

2028

Year

03

Month

08

Day

Date trial data considered complete

2028

Year

03

Month

08

Day

Date analysis concluded

2028

Year

03

Month

08

Day

Other related information

Registered date

2023

Year

10

Month

16

Day

Last modified on

2023

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059901