UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052512 |
|---|---|
| Receipt number | R000059901 |
| 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 |
| Date of disclosure of the study information | 2023/10/16 |
| Last modified on | 2024/10/17 21:24:57 |
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Basic information
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
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
Objectives
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
Assessment
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.
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
kmomose@shinshu-u.ac.jp
Public contact
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
20hm202k@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Kio Fukushima
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
Tel
0263-37-2572
md_rinri@shinshu-u.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
信州大学医学部保健学科
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
Results
Basic characteristics of the subjects were age 21.4 years, height 166.1 cm, weight 57.4 kg, and BMI 20.6. There were no significant differences in the results of the one way ANOVA from baseline to 30 minutes and 120 minutes for all experimental conditions (water intake, food intake, and exercise) in total body skeletal muscle mass, total body fat mass, or Phase Angle.
Results date posted
| 2024 | Year | 10 | Month | 17 | Day |
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
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
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059901
