UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052307 |
|---|---|
| Receipt number | R000059715 |
| Scientific Title | Efficacy evaluation study with replacement diet food |
| Date of disclosure of the study information | 2023/09/26 |
| Last modified on | 2024/03/25 16:01:13 |
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Basic information
Public title
Efficacy evaluation study with replacement diet food
Acronym
Efficacy evaluation study with replacement diet food
Scientific Title
Efficacy evaluation study with replacement diet food
Scientific Title:Acronym
Efficacy evaluation study with replacement diet food
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test foods will be used in conjunction with exercise; an exploratory evaluation will be conducted to determine the effect of the diet on weight loss when consumed for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight, body fat percentage, BMI, basal metabolic rate, abdominal circumference, thigh circumference, calf circumference, hip size, and arm circumference.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1.MENOLET black ginger grains: Once a day after dinner
2. MENOLET Replacement Drink: Once a day for a week after menstruation ends, in place of dinner.
Interventions/Control_2
Life goes on as usual.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1 Age: 20 years old or older, 49 years old or younger
2 Gender: Japanese female
3 BMI less than 30 kg/m2 (BMI between 23.0 kg/m2 and 30.0 kg/m2)
4 Regular menstrual cycle in the last 3 months (every 21-35 days cycle, menstruation 4-7 days)
5 The patient must start food intake at the end of menstruation and must be able to continue coming to the hospital according to the study schedule.
6. The applicant must be able to eat three meals a day during the study period, avoid binge drinking and excessive exercise, and maintain the same lifestyle (eating habits, exercise habits, etc.) as before the study period.
7 Applicants must be able to have a photo taken of their entire body with bare skin exposed at the time of the visit.
8 Those who are able to continue the specified exercise during the study period.
9 Persons who have received a full explanation of the purpose and content of the study, understand it well, voluntarily volunteer to participate, and agree to participate in the study in writing.
Key exclusion criteria
1 Those with a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
2 Those who have been diagnosed with or are taking medication for dyslipidemia, hypertension, or diabetes mellitus.
3 Patients who have been treated with medication or undergone surgery due to serious illness or injury within one month of the start of this study.
4. The subject is a regular user of foods for specified health use, functional foods, or nutritional supplements that may affect the study.
5 Pregnant, lactating, or wishing to become pregnant during the study period
6 Heavy drinkers of alcohol
7 Shift workers
8 Those who travel on average more than 10 days per month for business or pleasure trips.
9 Persons who may show allergic symptoms to any of the ingredients contained in the test food
10 Persons who are already participating in other clinical trials or will participate during the period of this study
11 Persons who are judged by the principal investigator to be unsuitable to participate in this study
12 Persons who habitually engage in exercise that causes muscle pain
13. Those who are on a restricted diet or diet, and those who plan to lose weight during the study period.
(Dieting is defined as weight loss through exercise and weight loss through reduced food intake.)
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Souichiro |
| Middle name | |
| Last name | Hosoya, |
Organization
TFC Research Inc.
Division name
representative director
Zip code
165-0033
Address
2-33-11 Wakamiya, Nakano-ku, Tokyo
TEL
080-3826-4026
info@tfc-r.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Co., Ltd
Division name
Pharmaceutical Development Division
Zip code
062-0933
Address
1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL
09031166218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
HRC Corporation
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
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel
011-771-1501
info@yurinokai.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
医療法人社団 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 26 | 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
| 2023 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059715
