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Effectiveness of time restricted diet versus a diet taken throughout the day on weight reduction and metabolic parameters in obese (BMI 25 kg/m2 to 35 kg/m2) individuals. A randomized controlled trial.
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SLCTR Registration Number
SLCTR/2018/001
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effectiveness of time restricted diet versus a diet taken throughout the day on weight reduction and metabolic parameters in obese (BMI 25 kg/m2 to 35 kg/m2) individuals. A randomized controlled trial.
Public Title of Trial
Effectiveness of time restricted diet versus a diet taken throughout the day on weight reduction and metabolic parameters in obese individuals.
Disease or Health Condition(s) Studied
Obesity
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1199-2785
Any other number(s) assigned to the trial and issuing authority
16/130 (ERC: Colombo)
What is the research question being addressed?
What is the effectiveness of a time restricted diet compared to a diet taken throughout the day in to reduce weight and to improve selected metabolic parameters in obese people (BMI 25 kg/m2 to 35 kg/m2)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study population will be selected from the in and out patient referrals to the Medical Nutrition Clinic (MNC), National Hospital of Sri Lanka (NHSL) according to the inclusion and exclusion criteria.
After recruiting the participants, using computer generated random numbers, stratified randomization will be done to allocate them in to three age groups (18-29 years,30- 39 years,40-50 years). Block randomization will be done in each age category to allocate participants to both groups (control and intervention arms). The selected patients will be assessed by with an interviewer administered questionnaire which include basic information by the co investigator.
Patient’s waist circumference and body fat percentage will be measured. Fasting blood sugar (FBS), HbA1C, Lipid profile, ALT, TSH will be done in all patients at baseline. These investigations will be done in all patients referred to the MNC routinely.
Total calorie requirement per day= Body weight * 25 kcal/kg/day. Patients will be given a calorie restriction, i.e. less 300-500 kcal/day to loose 1/2 kg per week
One group (Group 1) will be given the choice to take the restricted calorie intake at any time during the day.
Group 2 will be advised to take the calorie restricted diet during a twelve hour period (e.g. from 6am to 6pm).
The adherence to the given diet plan and exercise regimen will be monitored with frequent telephone calls (two times per week during the initial two weeks and once in two weekly for the rest of the three months.) Patients will be reviewed monthly at the Medical Nutrition Clinic, NHSL. Weight will be documented.
Weight, BMI, fat distribution, FBS, Lipid profile, HbA1C, ALT will be repeated and documented at the end of 3 months.
Inclusion criteria
Men and women aged 18-50 years with a BMI of 25 kg/m2 – 35 kg/m2.
Exclusion criteria
Primary outcome(s)
1.
Weight |
[ At baseline and at the end of 3 months ] |
2.
Fasting blood sugar level |
[ At baseline and at the end of 3 months ] |
3.
HbA1C level |
[ At baseline and at the end of 3 months ] |
4.
Lipid Profile |
[ At baseline and at the end of 3 months ] |
5.
Alanine transaminase level |
[ At baseline and at the end of 3 months ] |
Secondary outcome(s)
1.
None |
[ None ] |
Target number/sample size
156 (78 per arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-01-02
Anticipated end date
2018-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-12-15
Approval number
EC-16-130
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
Telephone: | +94-11-2695300 (Extension: 240) |
Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. W.C.K.Jayawardena
Senior Registrar in Endocrinology
Diabetes and Endocrinology Unit,
National Hospital of Sri Lanka
Mob: +94713485295
chathuri.jayawardena @yahoo.com
Contact Person for Public Queries
Dr. Noel Somasundaram
Consultant Endocrinologist
Diabetes and Endocrinology Unit,
National Hospital of Sri Lanka
Tel: +9411-2691111-2800
Mob: +94 773 660 923
noelsomasundaram@gmail.com
Primary study sponsor/organization
National Hospital of Sri Lanka
National Hospital of Sri Lanka, Colombo 10
Sri Lanka
Tel: +9411-2693510
http://www.nhsl.health.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results