UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048924 |
|---|---|
| Receipt number | R000055742 |
| Scientific Title | The effect of intake of plant extract test food on body fat: A randomized, double-blind, placebo-controlled clinical trial |
| Date of disclosure of the study information | 2022/09/14 |
| Last modified on | 2022/11/05 21:14:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of intake of plant extract test food on body fat: A randomized, double-blind, placebo-controlled clinical trial
Acronym
The effect of intake of plant extract test food on body fat: A randomized, double-blind, placebo-controlled clinical trial
Scientific Title
The effect of intake of plant extract test food on body fat: A randomized, double-blind, placebo-controlled clinical trial
Scientific Title:Acronym
The effect of intake of plant extract test food on body fat: A randomized, double-blind, placebo-controlled clinical trial
Region
| Asia(except Japan) |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of continuous intake of test food for 12 weeks on body weight in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
BMI, Body fat percentage,blood pressure, total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, glucose, uric acid, hemoglobin, questionnaire (WHOQOL-BREF, PSQI, BAZ)
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food A for 12 weeks
Interventions/Control_2
Intake of test food B for 12 weeks
Interventions/Control_3
Intake of placebo 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, Healthy adults aged 20 to 65;
2, Subjects who have not received any treatment;
3, Subjects who can provide their written informed consent.
Key exclusion criteria
1, Subjects with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic diseases;
2, Subjects who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items;
3, Subjects who are currently taking medications (including Chinese herbal medicines) ;
4, Subjects who whose daily life is extremely irregular;
5, Subjects who have difficulty consuming the study food as instructed;
6, Subjects with food allergies or those who may develop allergies related to the tested food items;
7, Subjects who are pregnant, in lactation, or planning to become pregnant;
8, Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial;
9, Other subjects were judged by the investigator to be unsuitable for the study.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Lei |
| Middle name | |
| Last name | Guan |
Organization
Skyherb Corporation
Division name
Functional Nutrition Institute
Zip code
313300
Address
No.398 Shuangqiao Rd., Anji County, Zhejiang China
TEL
+86-571-88053319
guanl@skyherb.cn
Public contact
Name of contact person
| 1st name | Ya fei |
| Middle name | |
| Last name | Wang |
Organization
Skyherb Corporation
Division name
Functional Nutrition Institute
Zip code
313300
Address
No.398 Shuangqiao Rd., Anji County, Zhejiang China
TEL
+86-571-88053319
Homepage URL
wangyf@skyherb.cn
Sponsor or person
Institute
Skyherb Corporation
Institute
Department
Personal name
Funding Source
Organization
Skyherb 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
Human Research Ethics Committee, Skyherb Corporation
Address
No.398 Shuangqiao Rd., Anji County, Zhejiang China
Tel
+86-571-88053319
guanl@skyherb.cn
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 | 09 | Month | 14 | 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
54
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
| 2022 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 16 | 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 | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
