UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038025 |
|---|---|
| Receipt number | R000043352 |
| Scientific Title | Effects of mild exercise after consumption of test beverage on lipid metabolism: A dose-finding study. |
| Date of disclosure of the study information | 2019/11/08 |
| Last modified on | 2024/05/21 13:36:16 |
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Basic information
Public title
Effects of mild exercise after consumption of test beverage on lipid metabolism: A dose-finding study.
Acronym
Effects of mild exercise after consumption of test beverage on lipid metabolism: A dose-finding study.
Scientific Title
Effects of mild exercise after consumption of test beverage on lipid metabolism: A dose-finding study.
Scientific Title:Acronym
Effects of mild exercise after consumption of test beverage on lipid metabolism: A dose-finding study.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We tested healthy males (aged 20-39) who performed mild exercise after consumption of a single dose of test beverage. The goal of this study is to dose-dependently examine the effect of mild exercise after consumption of test beverage on lipid metabolism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory quotient and lipid oxidation
Key secondary outcomes
Energy consumption and carbohydrate oxidation
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take a single dose of 200mL of placebo beverage.
Interventions/Control_2
Take a single low dose of 200mL of test beverage.
Interventions/Control_3
Take a single high dose of 200mL of test beverage.
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1. 20 to 39 years old (at the time of submission of an informed consent document).
2. Healthy individuals (those who were judged to be healthy by the principal investigator).
3. Males.
4. BMI 18.5 to 24.9 kg/m2
5. Those who can stay overnight the day before coming to the hospital.
6. Smartphone users (who can input their own data into the electronic diary).
7. Those who do not intend to change or do not change everyday lifestyle habits during the study period.
8. Those who can provide a written informed consent.
Key exclusion criteria
1. Those who are currently receiving drug treatments for some kind of illness (except for the drugs that are taken as needed).
2. Those who have seen a doctor regularly.
3. Those who have severe symptoms of anemia.
4. Those who have a current or a past medical history of the following severe diseases: diabetes, circulatory disease, hepatic disease, renal disease, and cardiac disease.
5. Those who have a current or a past medical history of drug and food allergies.
6. Those who regularly have a habit of taking the following products: pharmaceutical products, quasi-pharmaceutical products, health-promoting foods (Food for Specified Health Use), health foods, and supplements, or those who have a plan to take products listed above during the study period.
7. Those who consume 60 or more grams of alcohol per day.
8. Those who have a smoking habit.
9. Those who are currently receiving treatment for drug abuse and addiction or those who have a past medical history of drug abuse and addiction.
10. Those who are currently participating in another clinical trial.
11. Those who met the key exclusion criteria after the informed consent form was submitted.
12. Those who were determined by the principal investigator or a sub-investigator to be unsuitable for participation in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Oki |
Organization
Asahi Quality and Innovations, Ltd.
Division name
-
Zip code
302-0106
Address
1-21, Midori 1-chome, Moriya-shi, Ibaraki
TEL
0297-46-1111
koji.oki@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality and Innovations, Ltd.
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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel
03-6704-5968
jimukyoku@imeqrd.co.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
| 2019 | Year | 11 | Month | 08 | 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
14
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
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043352
