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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028927
Receipt No. R000033051
Scientific Title Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity
Date of disclosure of the study information 2017/09/05
Last modified on 2018/04/05

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Basic information
Public title Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity
Acronym Effects of health food products on weight loss in Japanese obese volunteers
Scientific Title Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity
Scientific Title:Acronym Effects of health food products on weight loss in Japanese obese volunteers
Region
Japan

Condition
Condition Obesity classification 1 and 2 as defined by the Japan Society for the Study of Obesity
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of test diets on body weight and BMI when ingested once to 6 times daily for 4 or 8 weeks and on changes in body weight and BMI 8 weeks after end of test diets in male and female volunteers whose obesity classification is 1 or 2. Changes in study variables over time will be investigated within each test diet and no inter-group comparisons will be made.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in body weight and BMI from baseline (before start of test diets) to end of test diets and 8 week thereafter, and changes in body weight and BMI from end of test diets to 8 weeks thereafter
Key secondary outcomes Changes over time in body weight, BMI, vital signs and clinical laboratory tests

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Subjects will consume one of the 4 test diets. Test diet A (low-carbohydrate, energy-restricted meal or snack; approx. 1400 kcal/day with approx. 25% of "available carbohydrates" [saccharides]) will be ingested 6 times/day for 8 weeks. Test diet B (moderately low-carbohydrate meal or snack; approx. 1400 kcal/day with approx. 40% of available carbohydrates) will be ingested 4 times/day for 8 weeks. Test diet C (low-carbohydrate, energy-restricted meal; approx. 250 kcal/meal with approx. 30% of available carbohydrates) will substitute one of 3 meals daily for 4 weeks. Test diet D (hummus 120 g; approx. 260-400 kcal/120 g with approx. 15% of available carbohydrates in average) will be ingested daily together with regular meals for 4 weeks.
Interventions/Control_2
Interventions/Control_3
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 Japanese adults who voluntarily give written informed consent; who wish to lose weight by ingesting health food products; whose BMI is >= 25.0 and < 35.0 when giving informed consent, i.e., obesity classification 1 or 2 as defined by the Japan Society for the Study of Obesity; and who are capable of recording body weight and other health-related data using the specified smartphone application
Key exclusion criteria Diabetic patients
History of previous or present illness that interferes with ethical conduct of the research as determined by the investigator, e.g., hepatic or renal disorder; cardiovascular, respiratory, endocrine, metabolic, nervous, or psychological disease (except hypertension and dyslipidemia)
Known drug or food allergy
History of previous or present drug or alcohol dependence
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisayoshi Daito
Organization Heishinkai Medical Group Incorporated, OCROM Clinic
Division name Director
Zip code
Address 4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
TEL 06-6330-8810
Email hisayoshi.daito@heishinkai.com

Public contact
Name of contact person
1st name
Middle name
Last name Hisayoshi Daito
Organization Heishinkai Medical Group Incorporated, OCROM Clinic
Division name Director
Zip code
Address 4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
TEL 06-6330-8810
Homepage URL
Email hisayoshi.daito@heishinkai.com

Sponsor
Institute InCROM Inc.
Institute
Department

Funding Source
Organization Partnership Support Project for Enhancement of Commercial and Service Competitiveness 2017 (New Partnership Support Program)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor InCROM Inc.
InCROM Plus Inc.
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 医療法人 平心会 OCROMクリニック(大阪府)/Heishinkai Medical Group Incorporated, OCROM Clinic (Osaka, Japan)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 05 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 A total of 93 subjects started the study diet. Of these 76 completed the study. 78 subjects who had evaluable efficacy data were included in the efficacy analysis set, comprising 13 subjects (M: 5, F: 8) for test diet A, 11 (M: 8, F: 3) for B, 27 (M: 13, F: 14) for C, and 27 subjects (M: 20, F: 7) for test diet D.
Percent changes in body weight from baseline to end of test diet and 8 weeks thereafter, and those from end of test diet to 8 weeks thereafter were as follows: -5.8%, -3.8%, 1.7% for diet A, -6.2%, -6.2%, 0.0% for B, -1.5%, -2.5%, -1.0% for C, and -0.0%, -0.5%, -0.4% for diet D. Body weight in diet A was significantly reduced from baseline to end of diet and 8 weeks thereafter, however, it was significantly increased from end of diet to 8 weeks thereafter. Body weight decreases in diets B and C were significant from baseline to end of diet and 8 weeks thereafter, whereas no differences were noted between end of diet and 8 weeks thereafter. Subjects consuming diet D did not show changes in body weight. Changes in BMI were comparable to those in body weight for all diet groups.
Decreases in blood pressure, triglycerides, total cholesterol, LDL cholesterol and gamma-GTP were observed for diets A and B. Three (3.2%) out of 93 subjects experienced a total of 3 adverse events related to test diet, all of which were mild in intensity and none of them were clinically significant.
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
2017 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 13 Day
Last follow-up date
2018 Year 02 Month 04 Day
Date of closure to data entry
2018 Year 02 Month 08 Day
Date trial data considered complete
2018 Year 02 Month 20 Day
Date analysis concluded
2018 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033051

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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