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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023808
Receipt No. R000027305
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
Date of disclosure of the study information 2016/08/29
Last modified on 2017/03/11

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Basic information
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
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

Objectives
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

Assessment
Primary outcomes Chages in BMI
Key secondary outcomes Chages in body weights, 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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute InCROM Inc.
Institute
Department

Funding Source
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

Other related organizations
Co-sponsor
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 大阪治験病院(大阪府)/ Medical Corporation Heishinkai OPHAC Hospital (Osaka prefecture)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 29 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000027305
Publication of results Unpublished

Result
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

Progress
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
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.


Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027305

Research Plan
Registered date File name
2017/03/06 R000027305_研究計画書.pdf

Research case data specifications
Registered date File name
2017/03/06 R000027305_統計解析計画書_v1.0.pdf

Research case data
Registered date File name
2017/03/06 R000027305_統計解析報告書_v1.0.pdf


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