UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055667 |
|---|---|
| Receipt number | R000063615 |
| Scientific Title | The effects of variations in macronutrient composition on biomarkers |
| Date of disclosure of the study information | 2024/09/29 |
| Last modified on | 2024/09/29 15:57:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of variations in macronutrient composition on biomarkers
Acronym
The effects of variations in macronutrient composition on biomarkers
Scientific Title
The effects of variations in macronutrient composition on biomarkers
Scientific Title:Acronym
The effects of variations in macronutrient composition on biomarkers
Region
| Japan |
Condition
Condition
Healthy young adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will explore, in an exploratory manner, the effects of a diet with large daily variations in major macronutrients on glucose metabolism, lipid metabolism, and health-related markers, to determine whether such dietary habits are effective in improving metabolic flexibility (insulin resistance) and maintaining health.
Basic objectives2
Others
Basic objectives -Others
24-hour blood glucose levels after eating different meals
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolic flexibility
Key secondary outcomes
24-hour blood glucose level
urinary metabolome
physical activity
appetite
gut microbiota
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The participants alternate between low-carb and low-fat days for six days. The combination of the low-carb and low-fat days results in a nutritionally balanced diet based on the Dietary Reference Intakes.
Interventions/Control_2
Participants will be required to eat a nutritionally balanced diet based on the dietary reference intakes for six days.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
23.5<BMI<30
Willing and able to consume the provided foods and beverages
Key exclusion criteria
Individuals taking regular medications that affect metabolism (e.g., diabetes treatments, alpha-blockers, beta-blockers).
Individuals with diseases that affect metabolism (e.g., diabetes, thyroid disorders).
Individuals diagnosed with or having a history of mental illness.
Individuals using implanted medical devices such as pacemakers.
Individuals with severe cardiovascular disease.
Individuals with cancer.
Individuals with oral or dental diseases, or those undergoing oral or dental treatment.
Individuals with a history of gastrointestinal surgery (primarily involving the esophagus, stomach, duodenum, small intestine, colon, or liver; appendectomy is allowed).
Individuals with gastrointestinal diseases.
Individuals with knee or back conditions that interfere with daily life.
Individuals with extremely irregular eating habits (e.g., frequent skipping of meals, picky eating, frequent snacking, or noticeable irregularities in meal times).
Individuals participating in or planning to participate in other studies involving the consumption of food, medication intake, or the application of cosmetics or medications.
Individuals with an exercise habit (those exercising for 60 minutes or more per day, at least four days per week).
Individuals engaged in heavy physical labor in daily life or planning to do so during the study period (such as physically demanding work, prolonged walking, or standing activities).
Individuals who regularly consume excessive alcohol (more than 60g of pure alcohol per day) or tobacco, and who cannot abstain from smoking or drinking for three days prior to the testing days during the study period.
Individuals with claustrophobia or a subjective fear of confined spaces.
Individuals with food allergies.
Other individuals deemed unsuitable by the principal investigator (Yoshinari Uehara, Fukuoka University) for the safe execution of this study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
8140180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
0928716631
yamatai0605@gmail.com
Public contact
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
yhatamoto@nibiohn.go.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
same as above
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
092-801-1011(3193)
fumed-ethics@fukuoka-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 29 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 29 | 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
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | 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=R000063615
