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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016772
Receipt No. R000019465
Scientific Title The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: A randomized controlled trial of two different diets
Date of disclosure of the study information 2015/03/11
Last modified on 2018/01/30

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Basic information
Public title The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: A randomized controlled trial of two different diets
Acronym The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP (Mini Egg study): A randomized controlled trial of two different diets
Scientific Title The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: A randomized controlled trial of two different diets
Scientific Title:Acronym The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP (Mini Egg study): A randomized controlled trial of two different diets
Region
Japan

Condition
Condition Overweight and Obesity
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the comparative effects of unbalanced diet and well-balanced diet on visceral fat loss in overweight and obese subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in visceral fat area
Key secondary outcomes Change and percent change in body weight, waist circumference, hip circumference, body fat, glucose-related markers, lipid markers, oxidative stress markers, blood biochemical parameters

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 An unbalanced diet (2096kcal; Protein=13.7%, Fat=37.5%, Carbohydrate/dietary fiber ratio >=15, omega-3/fat ratio <=0.04), for 2 weeks -> Washout, for 4 weeks -> A well-balanced diet (2096kcal; Protein=22.3%, Fat=20.8%, Carbohydrate/dietary fiber ratio <=15, omega-3/fat ratio >=0.04), for 2 weeks
Interventions/Control_2 A well-balanced diet (2096kcal; Protein=22.3%, Fat=20.8%, Carbohydrate/dietary fiber ratio <=15, omega-3/fat ratio >= 0.04), for 2 weeks -> Washout, for 4 weeks -> An unbalanced diet (2096kcal; Protein=13.7%, Fat=37.5%, Carbohydrate/dietary fiber ratio >=15, omega-3/fat ratio <= 0.04), for 2 weeks
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
59 years-old >=
Gender Male
Key inclusion criteria 1) Japanese male, Age >=20 and <=59 years
2) Body mass index >=23 kg/m2
3) Informed consent provided
4) Able to receive and cook experimental diet
5) Able to follow the instructions of the study team
6) Participated in a meal tolerance test
Key exclusion criteria 1) Plasma glucose value >=126 mg/dL (7.0 mmol/L), LDL-cholesterol value >=180 mg/dL (4.65 mmol/L), Triglyceride value >=300 mg/dL (3.4 mmol/L), Systolic blood pressure >=160 mmHg
2) Weight change during past 1 year >=3 kg
3) Severe liver dysfunction or renal dysfunction
4) Shift worker and night-shift worker
5) Food allergy and suspected food allergy (Self-reported)
6) An unbalanced diet (not able to eat fish and meat)
7) Poor physical health such as rapid weight loss during past 2 months
8) Plan to lose weight through vigorous exercise and resistance training
9) Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Sakane
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Division of Preventive Medicine
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL +81-75-641-9161
Email nsakane@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Sakane
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Division of Preventive Medicine
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL +81-75-641-9161
Homepage URL
Email nsakane@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization Biological Science Research, Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 11 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
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
2014 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2018 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019465

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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