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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038025
Receipt No. 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 2019/11/12

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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
Email koji.oki@asahi-qi.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL 03-6225-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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 03-6205-6222
Email suda-clinic_irb@imeq.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
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 No longer recruiting
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
2019 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043352

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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