UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044860 |
|---|---|
| Receipt number | R000051241 |
| Scientific Title | A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism -parallel-group, dose-comparison study- |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2024/05/17 12:02:24 |
* 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
A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism -parallel-group, dose-comparison study-
Acronym
A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism
Scientific Title
A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism -parallel-group, dose-comparison study-
Scientific Title:Acronym
A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effect of continuous intake of the test foods (high and low dose) on body weight-related QOL and lipid metabolism in males and females aged between 30 to 59 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire for body weight-related QOL
Key secondary outcomes
Body mass, waist circumference, blood pressure, total cholesterol, HDL, LDL, triglycerides, insulin, fasting blood glucose, gut microbiota (16S rRNA-seq), free fatty acids
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one packet the test food (250 mg/packet) at once a day.
Interventions/Control_2
Take two packets the test food (250 mg/packet) at once a day.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age between 30 to 59 years old.
2.Japanese males and females
3.Those who have high BMI.
4.Those who have defecation at least every day.
5.Those who can use smartphones or PC to record a diary.
6.Those who were given sufficient explanations of the trial information, and signed the document of the informed consent with well understanding for the trial objective; also, those who voluntarily joined the trial.
Key exclusion criteria
1.Those who are currently given any medical treatment with drugs or traditional Chinese medications.
2.Those who have medical treatments such a diet therapy and/or an exercise therapy.
3.Those who had been experiencing a severe disease.
4.Those who have currently been taking yogurts, Lactobacillus containing beverages, or Lactobacillus containing foods and supplements, which have health claims, for being healthy. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial.
5.Those who have currently been taking drugs, quasi-drug products, or foods and supplements which have health claims for promoting metabolism, improving fatigue and stress, and reducing blood pressure. However, those who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial.
6.Those who have a drug allergy or a food allergy, or those who had been experiencing these diseases.
7.Heavy drinkers who drink over 60 g alcohol/day.
8.Those who have a smoking habit (over 21 cigarettes/day).
9.Those who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period.
10.Those who work on night shift jobs and the shiftwork.
11.Those who are planning travels to foreign countries during the trial period.
12.Those who are currently pregnant or breastfeeding, or those who are planning to pregnant during the trial period.
13.Those who joined other clinical trials from 1 month before obtaining informed consent in this trial, or those who have currently been joined other clinical trials. Also, those who are planning to join other clinical trials.
14.Those who are unsuitable for this trial that judged by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Igari |
Organization
Daiwa Pharmaceutical Co., Ltd.
Division name
Department of Research and Development
Zip code
154-0024
Address
1-16-19 Sangenjaya, Setagaya-Ku, Tokyo, 154-0024, Japan
TEL
03-5430-4050
igari@daiwa-pharm.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
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
Daiwa Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
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
| 2021 | Year | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051241
