UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019241 |
|---|---|
| Receipt number | R000022189 |
| Scientific Title | The effects of the combination of glucosyl-hesperidin and caffeine on serum triglyceride and visceral fat in human dose-finding study:Double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2017/05/23 13:49:09 |
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Basic information
Public title
The effects of the combination of glucosyl-hesperidin and caffeine on serum triglyceride and visceral fat in human
dose-finding study:Double-blind, placebo-controlled trial
Acronym
The effects of the combination of glucosyl-hesperidin and caffeine on serum triglyceride and visceral fat in human
Scientific Title
The effects of the combination of glucosyl-hesperidin and caffeine on serum triglyceride and visceral fat in human
dose-finding study:Double-blind, placebo-controlled trial
Scientific Title:Acronym
The effects of the combination of glucosyl-hesperidin and caffeine on serum triglyceride and visceral fat in human
Region
| Japan |
Condition
Condition
moderately high body mass index (24-30 kg/m2) with 100-250 mg/dL serum triglycerid, healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-obesity effect of 12-week ingestion of the combination of glucosyl hesperidin and caffeine,
and to find the optimal dosage of caffeine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal fat area (subcutaneous fat area and visceral fat area) at 0 and 12-week ingestion period
Key secondary outcomes
At 0, 4, 8 and 12-week ingestion period
[1]serum triglyceride
[2]body weight
[3]body mass index (BMI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the control food (placebo,1 g/day,tablets) for 12 weeks
Interventions/Control_2
Oral ingestion of the test food 1 (containing 470 mg glucosyl hesperidin,1 g/day,tablets) for 12 weeks
Interventions/Control_3
Oral ingestion of the test food 2 (containing 470 mg glucosyl hesperidin and 25 mg caffeine,1 g/day,tablets) for 12 weeks
Interventions/Control_4
Oral ingestion of the test food 3 (containing 470 mg glucosyl hesperidin and 50 mg caffeine, 1 g/day,tablets) for 12 weeks
Interventions/Control_5
Oral ingestion of the test food 4 (containing 470 mg glucosyl hesperidin and 75 mg caffeine, 1 g/day,tablets) for 12 weeks
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]20-65 years old male and female
[2]serum triglyceride:100-250 mg/dL
[3]body mass index(BMI):24-30 kg/m2
Key exclusion criteria
[1]Subjects with drug or food allergy
[2]Subjects with a serious history in liver, kidney, heart, lung, or gastrointestinal (including gastric resection, except for the cecum resection)
[3]Subjects who donated 400 mL blood within 12 weeks, 200 mL within 4 weeks, or plasmapheresis within 2 weeks before starting of ingestion
[4]Subjects whose systolic blood pressure value are less than 90 mmHg
[5]Heavy users of alcohol, heavy smokers
[6]Subjects with extremely irregular eating habit, shifts workers, late-night workers
[7]Subjects taking medication or functional foods, influencing the results of this study, such as medicine, foods for specified health use, health foods.
[8]Subjects who drink a lot of drink containing caffeine (tea, coffee, Coke, etc)
[9]Female subjects who wish to become pregnant during the study period, (including the case who is suspected of being pregnant), or are pregnant or in nursing.
[10]Subjects participating in another study or finished prior study within 4 weeks
[11]Subjects deemed unsuitable by the investigator
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Yamamoto |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
Address
Imoji 3-20, Itami, Hyogo
TEL
072-778-1121
Yamamoto_Yoshihiro@house-wf.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohara |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
Address
Imoji 3-20, Itami, Hyogo
TEL
072-778-1127
Homepage URL
Ohara_Tatsuya@house-wf.co.jp
Sponsor or person
Institute
House Wellness Foods Corporation Research and Development Institute
Institute
Department
Personal name
Funding Source
Organization
House Wellness Foods Corporation
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
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
福原医院（北海道）
Fukuhara Clinic(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
http://nutritionj.biomedcentral.com/articles/10.1186/s12937-016-0123-7
Publication of results
Published
Result
URL related to results and publications
http://nutritionj.biomedcentral.com/articles/10.1186/s12937-016-0123-7
Number of participants that the trial has enrolled
Results
After 12 weeks intervention, decreases in abdominal fat area (AFA), especially subcutaneous fat area (SFA), were significantly greater in the G-hesperidin with 50-mg caffeine group and in the G-hesperidin with 75-mg caffeine group than in the placebo group.
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
| 2013 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 03 | 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
| 2015 | Year | 10 | Month | 05 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022189
| Research Plan | |
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| Registered date | File name |
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