UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049196 |
|---|---|
| Receipt number | R000055939 |
| Scientific Title | The effect of continuous intake of test foods on visceral fat area in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2022/10/12 11:06:21 |
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Basic information
Public title
The effect of continuous intake of test foods on visceral fat area: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym
The effect of continuous intake of test foods on visceral fat area
Scientific Title
The effect of continuous intake of test foods on visceral fat area in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
The effect of continuous intake of test foods on visceral fat area in healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of test food for reducing visceral fat area
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
1. Abdominal subcutaneous fat area and Abdominal total fat area
2. Body-mass index, Body weight, waist circumference and waist-hip ratio
3. Gut microbiota
4. Short chain fatty acids and bile acids in gut
3. Gut PH
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food three times a day for 12 weeks.
Interventions/Control_2
Consumption of the placebo food three times a day for 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese males and females who aged 20 to 65 at the time of informed consent.
2. Subjects whose BMI is 23 or more and less than 30 at screening.
3. Subjects who have breakfast, lunch, and dinner every day.
4. Those who can attend the examination site on the days of visit.
5. Those who can make self judgment to participate the study and are voluntarily giving written informed consent with signature and date.
Key exclusion criteria
1. Subjects who have a medical history of liver disease, kidney disease, cardiac disease, organ disorder, diabetes, and other serious diseases.
2. Subjects who have a history of gastrointestinal resection (excluding appendectomy and Endoscopic polypectomy).
3. Subjects who have a medical history of ileus, esophageal stricture and Abnormal intestinal narrowing.
4. Subjects who have chronic medical diseases under treatment.
5. Subjects who have a pacemaker or an implantable cardioverter defibrillator.
6. Subjects who are allergic to the test food (apple).
7. Subjects who are pregnant, lactation or planning to become pregnant.
8. Subjects whose daily average amount of drinking as pure alcohol is over 60 g.
9. Subjects Whose daily average number of smoking cigarettes is 21 or more.
10. Subjects who ingest pharmaceuticals, herbal medicines, and health foods for the purpose of weight loss.
11. Subjects who use engineered food or health foods high in dietary fiber that have a potentially effect on weight and lipid absorption.
12. Subject who are participating in other clinical studies. Or subject who plan to participate in the middle of this trial.
13. Subjects who are donated blood components 200 mL or more within a month before the screening test in this trial. Or subject who plan to donate blood components.
14. Subjects who have a habit of without a meal.
15. Subjects who work during 22 to 6 o'clock (including part-timer, as night shift worker).
16. Subjects who cannot prepare the test food according to instructions and take those three times when each meal.
17. Subjects who need to avoid consuming food whose origin is not clearly indicate due to religious or other reasons.
18. Subjects who are judged as ineligible to participate in the study by the physician.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
0040839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
0118820111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation Limited
Division name
Food Service Division
Zip code
0600061
Address
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061 Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Clinical Support Corporation Limited
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings 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
Institutional Review Board of Medical Corporation Hokubukai Utsukushigaoka Hospital
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-882-0111
matsuda@ughp-cpc.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
| 2022 | Year | 10 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | 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 | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055939
