UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: A randomized controlled trial of two different diets
Title of the study (Brief title)	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	Naoki Sakane
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
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	Naoki Sakane
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 24 Day
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

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Publication of results	Unpublished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