UMIN-CTR Clinical Trial

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
Email	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
Email	wangyf@skyherb.cn

Sponsor
Institute	Skyherb Corporation
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055742