UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016314 |
|---|---|
| Receipt number | R000018932 |
| Scientific Title | The study of Metabolic Improvement by Nutritional Intervention controlling Endogenous GIP: a meal tolerance test |
| Date of disclosure of the study information | 2015/01/23 |
| Last modified on | 2018/01/30 10:50:25 |
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Basic information
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
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 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
Assessment
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)
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 (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
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
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
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
nsakane@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Biological Science Research, Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 23 | 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 | 01 | Month | 26 | 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 | 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
