UMIN-CTR Clinical Trial

Public title

The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: a meal tolerance test

Acronym

The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: a meal tolerance test

Scientific Title

The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: a meal tolerance test

Scientific Title:Acronym

The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: a meal tolerance test

Region

Japan

Condition

Overweight and Obesity

Classification by specialty

Endocrinology and Metabolism

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to examine the comparative effects of an unbalanced diet and a well-balanced diet on gut hormones over 4 hours after eating in overweight and obese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gut hormones (Over 4 hours after eating)

Key secondary outcomes

Change and percent change in glucose-related markers, lipid markers, oxidative stress markers, experimental diet load test. (Over 4 hours after eating)

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

An unbalanced diet (636kcal; Protein=14.2%, Fat=34.4%, Carbohydrate/dietary fiber ratio >=15, omega-3/fat ratio <=0.04), a meal tolerance test. -> A well-balanced diet (661kcal; Protein=20.5%, Fat=22.6%, Carbohydrate/dietary fiber ratio <=15, omega-3/fat ratio >=0.04), a meal tolerance test.

Interventions/Control_2

A well-balanced diet (661kcal; Protein=20.5%, Fat=22.6%, Carbohydrate/dietary fiber ratio <=15, omega-3/fat ratio >= 0.04), a meal tolerance test. -> An unbalanced diet (636kcal; Protein=14.2%, Fat=34.4%, Carbohydrate/dietary fiber ratio >=15, omega-3/fat ratio <= 0.04), a meal tolerance test.

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

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

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

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

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

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name

Organization

Biological Science Research, Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

Date of disclosure of the study information

2015

Year

01

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

12

Month

24

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

23

Day

Last modified on

2018

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018932