UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029209 |
|---|---|
| Receipt number | R000033206 |
| Scientific Title | The effects of short term high fat diet on metabolism in non obese healthy Japanese men |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2019/03/22 10:52:36 |
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Basic information
Public title
The effects of short term high fat diet on metabolism in non obese healthy Japanese men
Acronym
The effects of short term high fat diet on metabolism in healthy men
Scientific Title
The effects of short term high fat diet on metabolism in non obese healthy Japanese men
Scientific Title:Acronym
The effects of short term high fat diet on metabolism in healthy men
Region
| Japan |
Condition
Condition
Lifestyle-related disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effects of short term high fat diet on metabolism in healthy non-obese Japanese men
Basic objectives2
Others
Basic objectives -Others
Metabolic changes after high fat diet
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of insulin sensitivity and metabolism after high fat diet for six days
Key secondary outcomes
After high fat diet for six days
-Body composition
-IMCL,IHL
-Gut hormones
-Change of substrate
-Intestinal flora
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Six days high fat diet
(approximately+45% calory overfeeding)
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
BMI range: 18.5-25 kg/m2
Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding
Key exclusion criteria
1,history of diabetes
2,history of food allergy
3,history of drug hypersensitivity
4,habitual drinker(ethanol=>30g/day)
5,history of hypertension or dyslipidemia
6,history of digestive system disease
7,history of digestive surgical operation
8,history of hepatitis B virus or hepatitis C virus
9,A bleeding tendency
10,history of heart disease
11,liver
dysfunction(AST,ALT:=>51U/L, gamma-GTP=>101U/L) or renal dysfunction(urinary protein2+,uric blood2+,creatinine level=>1.3mg/dl)
12,Recent weight changes or attemps to lose weight(3kg weight gain or loss,within last 1 month)
13,low-carbohydrate diet(carbohydrate under 150g/day)
14,current smoker
15,subjects judged unsuitable to the study from staff(for example for MRI)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Tamura |
Organization
University of Juntendo
Division name
Department of Endocrinology and Metabolism
Zip code
Address
2-1-1, Hongo, Bunkyo-ku,Tokyo 113-8421 JAPAN
TEL
03-3813-3111
ys-tamur@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kadowaki,Daisuke Sugimoto |
Organization
University of Juntendo
Division name
Department of Endocrinology and Metabolism
Zip code
Address
2-1-1, Hongo, Bunkyo-ku,Tokyo 113-8421 JAPAN
TEL
03-3813-3111
Homepage URL
skadowa@juntendo.ac.jp
Sponsor or person
Institute
University of Juntendo
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Techonology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 10 | 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
| 2016 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033206
