UMIN-CTR Clinical Trial

Public title

A health monitoring study of healthy meal intake in Japanese adults with level 1 or higher obesity level of the criteria by Japan Society for the Study of Obesity

Acronym

A health monitoring study of healthy meal intake in Japanese adults with level 1 or higher obesity level of the obesity criteria

Scientific Title

A health monitoring study of healthy meal intake in Japanese adults with level 1 or higher obesity level of the criteria by Japan Society for the Study of Obesity

Scientific Title:Acronym

A health monitoring study of healthy meal intake in Japanese adults with level 1 or higher obesity level of the obesity criteria

Region

Japan

Condition

Japanese adults with level 1 or higher obesity of the criteria by Japan Society for the Study of Obesity

Classification by specialty

Medicine in general

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of the prescribed healthy meal (3 times a day + snack) for 28 days on BMI, body weight, vital signs, and clinical laboratory tests in Japanese male or female adults with level 1 or higher obesity level of the criteria by Japan Society for the Study of Obesity

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Chages in BMI

Key secondary outcomes

Chages in body weights, 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

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

To investigate changes in BMI, body weight, and vital signs at 2 and 4 weeks after taking the prescribed healthy meal (3 times a day + snack) for 28 days.

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

1. The subject who was given explanation about the objective, methods, study period, and expected detriment, etc. of this study, understood them, and gave informed consent on a voluntary basis.
2. The Japanese adult male or female aged 20 to 65 years, inclusive, at the time of informed consent
3. The subject whose BMI is 25.0 or over (level 1 or higher obesity level of the obesity criteria by Japan Society for the Study of Obesity)
4. The subject who can comply with the study rules and communicate subjective symptoms, etc.

Key exclusion criteria

1. The subject who has hepatic, renal, cardiovascular, respiratory, endocrine system, metabolic, neurological, or psychiatric disorder, or who was assessed to have a past history of any of these diseases by the principal investigator or subinvestigators (excluding subjects with lifestyle related diseases including hypertension, dyslipidemia, or diabetes mellitus who were assessed eligible for this study by the principal investigator)
2. The subject who has drug or food allergy
3. The subject who has drug or alcohol dependence
4. In addition, the subject who was assessed ineligible for the study by the principal investigator or subinvestigators

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Mikami

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

Hospital Director

Zip code

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003, JAPAN

TEL

06-6395-9000

Email

hiroshi.mikami@heishinkai.com

Name of contact person

1st name
Middle name
Last name	Hiroshi Mikami

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

Hospital Director

Zip code

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003, JAPAN

TEL

06-6395-9000

Homepage URL

Email

hiroshi.mikami@heishinkai.com

Institute

InCROM Inc.

Institute

Department

Personal name

Organization

Support Project to Strengthen Commerce and Service Competitiveness for year 2016 (New Cooperation Support Project by METI(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

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 大阪治験病院（大阪府）/ Medical Corporation Heishinkai OPHAC Hospital (Osaka prefecture)

Date of disclosure of the study information

2016

Year

08

Month

29

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000027305

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

<Results>
This study started on October 3, 2016 and ended on December 22, 2016.
Out of 31 subjects who gave informed consent, 30 subjects completed the study excluding 1 subject with BMI > 25. The number of subjects was 15 each for male and female. The means +/- SDs of age, height, weight and BMI of the subjects were 45.2 +/- 9.9 years, 163.88 +/- 7.66 cm, 76.50 +/- 12.54 kg, and 28.34 +/- 3.74. Those of female subjects were 44.7 +/- 9.9 years, 157.70 +/- 4.08 cm, 71.77 +/- 13.33 kg, and 28.72 +/- 4.66. Those of male subjects were 45.7 +/- 10.1 years, 170.06 +/- 4.8 cm, 81.23 +/- 10.00 kg, and 27.97 +/- 2.64.
The means +/- SDs of BMI, which was the primary endpoint in this study, at pre-study food intake, at post-2weeks, and at post-4 weeks of study food intake were 28.34 +/- 3.74, 27.42 +/- 3.66, and 26.80 +/- 3.59, respectively. Those of females were 28.72 +/- 4.66, 27.83 +/- 4.64, 27.27 +/- 4.54, and those of males were 27.97 +/- 2.64, 27.01 +/- 2.43, and 26.33 +/- 2.38. The statistical test indicated that BMI significantly decreased at post-2 weeks and 4 weeks of study food intake (p<0.0001 each).
The mean +/- SD of body weight, which was the secondary endpoint, at pre-study food was 76.50 +/- 12.54 kg, whereas those at post-2 weeks and 4 weeks of study food intake were 73.82 +/- 12.16 kg and 72.19 +/- 11.85 kg. In female subjects, that at pre-study food was 71.77 +/- 13.33 kg, whereas those at post-2 weeks and 4 weeks of study food intake were 69.42 +/- 13.15 kg and 68.11 +/- 12.85 kg. In male subjects, that at pre-study food was 81.23 +/- 10.00 kg, whereas those at post-2 weeks and 4 weeks of study food intake were 78.23 +/- 9.57 kg and 76.27 +/- 9.49 kg.
Refer to statistical analysis report for details of statistical analysis 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

Recruitment status

Completed

Date of protocol fixation

2016

Year

08

Month

25

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

03

Day

Last follow-up date

2016

Year

12

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2017

Year

01

Month

30

Day

Other related information

<Discussion>
Currently, various healthy foods arrive in stores and healthy foods are easily available through internet. In these circumstances, knowledge about healthy foods is important for customers. On the other hand, companies producing healthy foods need to develop menus ensuring customers surely and safely manage their health condition and to give correct knowledge about the effect and the contents of foods.
This study was conducted in Japanese adults whose obesity classification >= 1 based on Japan Society for the Study of Obesity and BMI >= 25.0 using healthy foods of InCROM Plus Inc. as study food. The effects of study food intake 3 times daily (breakfast, lunch, and dinner) and study snack intake for 28 days on BMI, body weight, vital signs, and clinical laboratory tests were assessed.

BMI, which was the primary endpoint, significantly decreased at post-2 weeks and 4 weeks study food intake from pre-study food (p<0.0001 each). Mean body weight in all subjects and mean BMI and mean body weight by gender also decreased at post-2 weeks and 4 weeks study food intake. These suggest that the intake of healthy food of InCROM Plus Inc. decreases bodyweight significantly and safely.

Many people show a great interest in healthiness through diet and more and more people are taking healthy foods. While at the same time, information about health promotion unsupported by fact is flooding and customers have difficulty using appropriate healthy foods. In these situations, buildup of knowledge about efficacy and safety of healthy foods through clinical trial including this study will be a guidepost for selecting healthy foods.
<Conflict of Interest>
This study was conducted by personal funds of InCROM Inc. and partly funded by Support for SMEs New Business Activities in Japan for year 2017 of Small and Medium Enterprise Agency.

Registered date

2016

Year

08

Month

29

Day

Last modified on

2017

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027305