UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047213 |
|---|---|
| Receipt number | R000053745 |
| Scientific Title | Effects of a Functional Food for a Subject of the Specific Health Guidance. |
| Date of disclosure of the study information | 2023/03/18 |
| Last modified on | 2022/06/17 17:33:42 |
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Basic information
Public title
Effects of a Functional Food for a Subject of the Specific Health Guidance.
Acronym
Effects of a Functional Food for a Subject of the Specific Health Guidance.
Scientific Title
Effects of a Functional Food for a Subject of the Specific Health Guidance.
Scientific Title:Acronym
Effects of a Functional Food for a Subject of the Specific Health Guidance.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of a functional food for body fat and other indexes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
*Secondary indexes
[1] Waist circumference
[2] BMI
[3] Blood triglyceride level
[4] HDL-cholesterol level
[5] Blood pressure
[6] Blood glucose level
[7] HbA1c
[8] Ratio of those who achieved weight loss of 2 kg and abdominal circumference reduced by 2 cm (achievement of specific health guidance goals)
[9] Ratio of people who are actively supported by specific health guidance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of healthy meals (one time in a day [eating for lunch; 12 weeks] from every Monday to Friday).
Interventions/Control_2
Oral intake of normal meals (keeping habit of eating before participating with the study; 12 weeks).
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Healthy Japanese females aged 40-64 years.
[2] Individuals who have stable eating habits for breakfast, lunch, and dinner, and no unbalanced diet.
[3] Individuals who are the subject of the Specific Health Guidance designated by the Ministry of Health Labour and Welfare (a subject of an active support).
(Criteria)
Meet the criterion 1 and at least 2 items from criterion 3, or meet the criterion 2 and at least 3 items from criterion 3.
1) Abdominal circumference: over 90 cm.
2) BMI: over 25 kg/m2.
3)Additional conditions:
* A smoker.
* Blood glucose:
fasting blood glucose: over 100 mg/dl or HbA1c: over 5.6%.
* Lipids:
Triglycerides: over 150 mg/dl or HDL-Cho: less than 40 mg/dl
*Blood pressure:
systolic blood pressure: over 130 mmHg and/or diastolic blood pressure: 85 mmHg.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals who have difficulty in intaking a test food as a weekday lunch for 12 weeks continuously during the study period.
[2] Individuals who sometimes misses lunch on weekdays. And individuals who have difficulty intaking a test food as lunch.
[3] Individuals who are receiving the Specific Health Guidance. Or individuals who may receive the Specific Health Guidance during the test period.
[4] Individuals who are scheduled to undergo a medical examination during the test period.
[5] Individuals who are in constipation.
[6] Individuals using medical products.
[7] Individuals who have a history of or are a patient of mental illness, sleep disorders, diabetes or serious illness.
[8] Individuals with metal in their body that cannot be removed. Individuals with a cardiac pacemaker.
[9] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[10] Individuals who contract or have a history of serious endocrine disease.
[11] Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month.
[12] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[13] Individuals who are sensitive to test product or other foods, and medical products.
[14] Individuals who excessively take alcohol.
[15] Individuals who have and have had within the past three months the habit of continuously intaking foods for food for Specified Health Uses, Foods with Functional Claims, and health foods that claim to reduce lipid metabolism, glucose metabolism, blood pressure, visceral fat and body fat, and who plan to intake these foods during the test period.
[16] Individuals who are or are possibly pregnant, or are lactating.
[17] Individuals who participated in other clinical studies in the past 3 months.
[18] Individuals who are or whose family is engaged in health foods of functional foods.
[19] Individuals judged inappropriate for the study by the principal.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Non-disclosure
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
i.takahashi@tes-h.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
| 2023 | Year | 03 | Month | 18 | 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
| 2022 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053745
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