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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. -

SLCTR Registration Number

SLCTR/2018/001


Date of Registration

02 Jan 2018

The date of last modification

Jan 08, 2018



Application Summary


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 of 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)


Trial Details


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


Assignment

Parallel


Purpose

Supportive care


Purpose


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

  1. Patients with identified secondary cause for obesity
  2. Inability to adhere to the suggested meal plan and exercise regimen.
  3. Any underlying medical condition which can interfere with the proposed dietary plan and exercise regimen (i.e. diabetes mellitus, Cushing’s disease, rheumatoid arthritis and osteoarthritis of knees.)
  4. Patients who are on drugs which can interfere with the proposed diet (i.e prednisolone)
  5. Women who are pregnant or breast feeding
  6. Patients with diagnosed psychiatric disorder.


Primary outcome(s)

  1. Weight
  2. Fasting blood sugar level
  3. HbA1C level
  4. Lipid Profile
  5. Alanine transaminase level

Primary outcome(s) - Time of assessment(s)

At baseline and at the end of 3 months


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by Ethics Committee Faculty of Medicine Colombo (Ref: ERC/16/130)


Funding source

None (Investigator funded)



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None