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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019241
Receipt No. 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

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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
Email 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
Email Ohara_Tatsuya@house-wf.co.jp

Sponsor
Institute House Wellness Foods Corporation Research and Development Institute
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022189

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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