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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047996
Receipt No. 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

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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
Email 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
Email hosam.refaei@yahoo.com

Sponsor
Institute Port said University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054713

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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