UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014525 |
|---|---|
| Receipt number | R000016880 |
| Scientific Title | A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome |
| Date of disclosure of the study information | 2014/07/31 |
| Last modified on | 2014/07/09 18:51:55 |
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Basic information
Public title
A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome
Acronym
Efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome
Scientific Title
A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome
Scientific Title:Acronym
Efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome
Region
| Japan |
Condition
Condition
Metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area, body weight(body mass index), abdominal circumstance, blood pressure, triglyceride, HDL-cholesterol, blood glucose
Key secondary outcomes
Subcutaneous fat area, total fat area, adiponectin, HMW adiponectin, leptin, adiponectin/ leptin, HMW adiponectin/ total adiponectin, HMW adiponectin/ leptin, questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of placebo capsules for 12 consecutive week
Interventions/Control_2
Ingestion of capsules include extract of pericarp of mangosteen and extract of lychee for 12 consecutive weeks
Interventions/Control_3
Ingestion of capsules include extract of pericarp of mangosteen for 12 consecutive 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese males and females between the ages of 35 and 65
2. abdominal circumference greater or equal 85cm in males and 90 cm in female on preliminary examination
3. applicable to more than two of three following indexes on preliminary examination; blood pressure greater or equal 130/85 mm Hg, triglycerides greater or equal 150mg/dL or serum high-density lipoprotein cholesterol (HDL-C) less 40 mg/dL, blood glucose greater or equal 110 mg/dL, body weight less100 kg, or body mass index greater or equal 25 kg/m2
Key exclusion criteria
1. having exercise or diets for reducing body weight
2. having the medicines or dietary supplements affecting body fat, serum triglyceride, or lipid metabolism potentially
3. having foods fortified with mangosteen or lychee extracts
4. with severe abnormalities of blood pressure or blood test
5. excessive habitual smoker or alcohol addict or extremely irregular food habits person
6. with severe disease receiving treatment
7. needing emergent treatment to diabetes, hepatopathy, renal or heart disease
8. having possibilities of emerging allergy related to the study
9. with pregnant (including with pregnant in plan), or in the lactation period
10. judged to be inadequate by the questionnaire of lifestyles
11. judged to be inadequate by biochemical assessment in blood on preliminary examination
12. taking part in other clinical trials within a month from the initiation of this clinical trial
13. judged to be inadequate by the doctors responsible for this clinical study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Kondo |
Organization
Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name
Director
Zip code
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka 553-0004
TEL
06-6441-6848
ko283434@ares.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muneaki Iizuka |
Organization
Total Technological Consultant Co., Ltd.(TTC)
Division name
Clinical Research Planning Dept.
Zip code
Address
1-20-2 Ebisu Nishi, Shibuya-ku, Tokyo 150-0021, Seibu Shinyokinko Ebisu Bldg
TEL
03-5459-5329
Homepage URL
m.iizuka@ttc-tokyo.co.jp
Sponsor or person
Institute
Total Technological Consultant Co., Ltd.(TTC)
Institute
Department
Personal name
Funding Source
Organization
Lotte 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
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
医療法人健昌会 福島健康管理センター（Medical Corporation Kenshokai，Fukushima Healthcare Center）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 31 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 04 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 09 | Day |
Last modified on
| 2014 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016880
