UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028820 |
|---|---|
| Receipt number | R000032978 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Reducing Body Fat by Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2018/03/01 15:49:49 |
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Basic information
Public title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Reducing Body Fat by Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice
Acronym
Effects of Reducing Body Fat by Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Reducing Body Fat by Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice
Scientific Title:Acronym
Effects of Reducing Body Fat by Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits associated with daily Okinawa-Shiikuwasha juice ingestion for 12 weeks on body fat and also to investigate the potential health benefits of Okinawa-Shiikuwasha juice including improvement in lipid and glucose metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Abdominal visceral fat area after 4, 8 and 12 weeks of ingestion
Key secondary outcomes
Abdominal total fat area, abdominal subcutaneous fat area, body weight, BFP, BMI, waist circumference, hip circumference, waist-hip ratio, TC, LDL-C, HDL-C, TG, LDL-C/HDL-C, non-HDL, fasting blood glucose levels, HbA1c, insulin, HOMA-IR, adiponectin and leptin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 190 ml of Okinawa-Shiikuwasha juice (from concentrate) daily for 12 weeks.
Interventions/Control_2
Ingestion of 190 ml of Okinawa-Shiikuwasha juice (double strength) daily for 12 weeks.
Interventions/Control_3
Ingestion of 190 ml of placebo beverage daily for 12 weeks.
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. Subjects whose BMI is>=23 kg/m2 and <30 kg/m2.
2. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria
1. Subjects who are under physician's advice, treatment and/or medication for obese, hyperlipidemia and diabetes.
2. Subjects who regularly take anticoagulants (warfarin, etc.) or antiaggregant (aspirin, clopidgrel, ticlopidine, cilostazol, etc.)
3. Subjects whose BMI is >=30 kg/m2.
4. Subjects with familial hypercholesterolemia.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
6. Pacemaker or defibrillator users.
7. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
8. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
9. Subjects with severe anemia.
10. Pre- or post-menopausal women complaining obvious physical changes.
11. Subjects who are at risk of having allergic reactions to drugs or foods based on especially citrus fruits.
12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFP.
13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels.
14. Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism.
15. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle.
16. Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study.
17. Pregnant or lactating women or women expect to be pregnant during this study.
18. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
19. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Okinawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Clock Work Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032978
