UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hisayoshi Daito
Organization	Heishinkai Medical Group Incorporated, OCROM Clinic
Division name	Director
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	Hisayoshi Daito
Organization	Heishinkai Medical Group Incorporated, OCROM Clinic
Division name	Director
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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