UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047996 |
|---|---|
| Receipt number | R000054713 |
| Scientific Title | Hepatic fatty effects of very low-calorie ketogenic diet versus a low-carbohydrate diet in patients with class 1 obesity. |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/06/08 22:21:31 |
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Basic information
Public title
Hepatic fatty effects of very low-calorie ketogenic diet versus a low-carbohydrate diet in patients with class 1 obesity.
Acronym
Hepatic fatty effects of diet in patients with class 1 obesity.
Scientific Title
Hepatic fatty effects of very low-calorie ketogenic diet versus a low-carbohydrate diet in patients with class 1 obesity.
Scientific Title:Acronym
Hepatic fatty effects of diet in patients with class 1 obesity.
Region
| Africa |
Condition
Condition
Fatty liver
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare between the effect of very low-calorie ketogenic diet (VLCKD) and low-carbohydrate diet (LCD) on two fatty liver.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare between the effect of very low-calorie ketogenic diet (VLCKD) and low-carbohydrate diet (LCD) on two fatty liver.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Very low-calorie ketogenic diet
Interventions/Control_2
Low-carbohydrate diet
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Obesity
Key exclusion criteria
Malignancy
Target sample size
264
Research contact person
Name of lead principal investigator
| 1st name | Asmaa |
| Middle name | S. |
| Last name | Mohamed |
Organization
Faculty of Pharmacy, Port said University, Port said, Egypt.
Division name
Clinical Pharmacy Departement
Zip code
42534
Address
Port said, Egypt.
TEL
01066953443
Asmaa.Mohamed@pharm.psu.edu.eg
Public contact
Name of contact person
| 1st name | Hosam |
| Middle name | M. |
| Last name | Ahmad |
Organization
Egypt Ministry of Health and population
Division name
Internal Medicine and biomedical chemistry
Zip code
61516
Address
Minia, Egypt
TEL
01000638308
Homepage URL
hosam.refaei@yahoo.com
Sponsor or person
Institute
Port said University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Pharmacy, Port said University
Address
Port said, Egypt.
Tel
066 3402344
Asmaa.Mohamed@pharm.psu.edu.eg
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
| 2022 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054713
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