Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000189325
Ethics application status
Approved
Date submitted
17/12/2016
Date registered
3/02/2017
Date last updated
3/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Intermittent fasting in patients with liver fibrosis
Scientific title
Impact of Intermittent fasting on LDL cholesterol and fibrosis levels in patients with liver fibrosis
Secondary ID [1] 289168 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic fibrosis 298696 0
Condition category
Condition code
Metabolic and Endocrine 298752 298752 0 0
Metabolic disorders
Oral and Gastrointestinal 301348 301348 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subjects will perform intermittent fasting during 3 months . Participants will consume no food or drinks asides from the exceptions listed between 20:00 and 13:00 the following day, three days per week for three months.
They could drink some Infusions, water or coffee during the period of voluntary fasting. They can not combine with milk, sweeteners like sugar, saccharin or derivatives.
Participants will fill in a table with their food diary
We´ll do a blood test before the procedure (month 0), during (2 months) and the end of the study (3 months).
Intervention code [1] 296699 0
Treatment: Other
Comparator / control treatment
Subjects who do not perform intermittent fasting intervention
Control group
Active

Outcomes
Primary outcome [1] 300556 0
Evaluate the effects during 3 months of Intermittent fasting, on changes in LDL cholesterol, using blood test.
Timepoint [1] 300556 0
Pre-treatment, two months and the end of intervention. We´ll do three measurements
Primary outcome [2] 300557 0
Evaluate the effects of the Intermittent fasting, on severity of fibrosis, assessed by elastography
Timepoint [2] 300557 0
Pre-treatment, two months and the end of intervention. We´ll do three measurements
Secondary outcome [1] 330296 0
Evaluate the effects during 3 months of Intermittent fasting, on changes in glucose , using blood test.
Timepoint [1] 330296 0
Pre-treatment, two months and the end of intervention. We´ll do three measurements

Eligibility
Key inclusion criteria
Inclusion criteria will be subjects of both sexes who have hepatic fibrosis, aged between 18 and 65 years, must have fasted for at least 8 hours
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects presenting the following could not participate in the study (i) pregnant women, (ii) psychotic problems, (iii) primary cancer or current metastases, (iv) current gastrointestinal bleeding, (v) liver transplants ( vi) polycystic liver or hepatobiliary infarction (vii) intraabdominal infection or inflammation in acute phase, (viii) decompensated heart failure (ix) subjects who are receiving chemotherapy and / or radiotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8516 0
Spain
State/province [1] 8516 0
Madrid

Funding & Sponsors
Funding source category [1] 295207 0
University
Name [1] 295207 0
Camilo Jose Cela University
Country [1] 295207 0
Spain
Funding source category [2] 295208 0
Hospital
Name [2] 295208 0
Hospital Clinico San Carlos
Country [2] 295208 0
Spain
Primary sponsor type
University
Name
Camilo Jose Cela University
Address
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country
Spain
Secondary sponsor category [1] 294039 0
Hospital
Name [1] 294039 0
Hospital Clinico San Carlos
Address [1] 294039 0
Calle del Prof Martin Lagos, s/n, 28040 Madrid
Country [1] 294039 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296557 0
Camilo Jose Cela University
Ethics committee address [1] 296557 0
· C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Ethics committee country [1] 296557 0
Spain
Date submitted for ethics approval [1] 296557 0
14/04/2016
Approval date [1] 296557 0
18/04/2016
Ethics approval number [1] 296557 0

Summary
Brief summary
The Impact of Intermittent fasting has been recommended in several types of disorders in order to increase and improve the liver function. However, there are no studies to support its effectiveness. Therefore, through the Doppler ultrasound, we inten to evaluate the effect of Impact of Intermittent fasting on changes in LDL cholesterol and glucose in patients with liver fibrosis. The conceptual hypothesis of our study will be that "the Intermittent fasting improves LDL cholesterol and glucose," so that Intermittent fasting may change the function of the viscera itself.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65710 0
Prof Alvaro Otero Campos
Address 65710 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 65710 0
Spain
Phone 65710 0
+34618910140
Fax 65710 0
Email 65710 0
[email protected]
Contact person for public queries
Name 65711 0
Prof Alvaro Otero Campos
Address 65711 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 65711 0
Spain
Phone 65711 0
+34618910140
Fax 65711 0
Email 65711 0
[email protected]
Contact person for scientific queries
Name 65712 0
Dr Juan Pablo Hervas
Address 65712 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 65712 0
Spain
Phone 65712 0
+34639136120
Fax 65712 0
Email 65712 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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