UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

InCROM Inc.

Institute

Department

Personal name

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

Co-sponsor

InCROM Inc.
InCROM Plus Inc.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

09

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

08

Month

31

Day

Last modified on

2018

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033051