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Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

Primary Purpose

Obesity, Metabolic Syndrome, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Time Restricted Feeding
Standard Care
Sponsored by
RCSI & UCD Malaysia Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 20-59 years of age
  2. BMI 27.5kg/m2 - 39.9kg/m2
  3. Smart phone users
  4. Willing to lose weight
  5. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.

Exclusion Criteria:

  1. Those with history of cardiovascular disease, cerebrovascular accidents, degenerative or inflammatory diseases of the nervous system; epilepsy, malignancy, gastrointestinal disorders, thyroid disorders, diabetes or medications which could have had metabolic effects.
  2. Women who are pregnant or breastfeeding.
  3. Those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months.
  4. Subjects with any medical condition, which in the investigator's judgment may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
  5. Those currently on medication for chronic illness.
  6. Permanent night shift worker
  7. Those who need to practise Ramadan fasting during the period of this study.

Sites / Locations

  • Penang General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)

Standard Malaysian Healthy Plate (QQH)

Arm Description

Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).

Subjects practise the QQH dietary plan.

Outcomes

Primary Outcome Measures

Body weight (kg)
Mean body weight change will be calculated.
Systolic BP (mmHg)
This is a parameter for the calculation of metabolic syndrome severity score.
Fasting blood sugar (mmol/L)
This is a parameter for the calculation of metabolic syndrome severity score.
Waist circumference (cm)
This is a parameter for the calculation of metabolic syndrome severity score.
Serum triglyceride(mmol/L)
This is a parameter for the calculation metabolic syndrome severity score.
Serum high density lipoprotein (HDL) (mmol/L)
This is a parameter for the calculation metabolic syndrome severity score.

Secondary Outcome Measures

Number of fasting hours per day
For assessment of adherence
Number of days achieving TRF
For assessment of adherence
Incidence of treatment-emergent adverse events [Safety ]

Full Information

First Posted
January 19, 2020
Last Updated
May 17, 2022
Sponsor
RCSI & UCD Malaysia Campus
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1. Study Identification

Unique Protocol Identification Number
NCT04243746
Brief Title
Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk
Official Title
Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RCSI & UCD Malaysia Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The obesity rate in Malaysia is higher than the average world obesity rate. Central obesity is a component of metabolic syndrome (MetS) which is also made up of dyslipidemia, impaired glucose tolerance, and hypertension. MetS is a continuum in the risk of developing cardiometabolic complication. Time Restricted Feeding (TRF) involves an extended physiological overnight fast. Researchers believe that the timing of meal intake that matches with the circadian rhythms is as important as the calories intake to prevent obesity and its complications. The investigators hypothesize that TRF is effective in weight control and improvement of metabolic severity. Subjects will be randomized into either the control group, which practices QQH dietary plan or intervention group, which practices TRF as an adjunct to QQH dietary plan. Subjects will be followed up at week 12 and week 24 to assess adherence, efficacy and safety of TRF. This study intends to fill a few research gaps as follows: Longer study duration of 6 months. This is the first study amongst the Asian population. Adherence level to TRF in real life setting is measured. This information can potentially predict the intensity level of TRF that are feasible for practice in real life and also its association with the efficacy of TRF. TRF is defined as eating within a≤12-hour period and fasting for at least 12 hours per day. This is the shortest fasting window studied so far.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome, Pre Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)
Arm Type
Experimental
Arm Description
Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).
Arm Title
Standard Malaysian Healthy Plate (QQH)
Arm Type
Active Comparator
Arm Description
Subjects practise the QQH dietary plan.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Feeding
Intervention Description
Subjects practise TRF (2-3 meals) as an adjunct to the QQH healthy plate diet. Subjects of the intervention group can eat during the pre-determined 8-12 hours eating window, but they are only allowed to drink water and calorie-free drinks for the remaining 12-16 hours. Subjects are allowed to decide the time of their first and the last meal of the day as long as they eat within the 8-12 hour window period. However, skipping breakfast and having late dinner are discouraged.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Subjects practice the QQH healthy plate diet as per guidelines set by the Health Ministry the guidelines.QQH refers to a normal food plate (23cm in diameter), divided into a quarter of rice (carbohydrates), a quarter of meat (protein) and a half plate of vegetables and fruits. Additionally, no calories specification is required and snacks are discouraged.
Primary Outcome Measure Information:
Title
Body weight (kg)
Description
Mean body weight change will be calculated.
Time Frame
baseline - 24 weeks
Title
Systolic BP (mmHg)
Description
This is a parameter for the calculation of metabolic syndrome severity score.
Time Frame
baseline - 24 weeks
Title
Fasting blood sugar (mmol/L)
Description
This is a parameter for the calculation of metabolic syndrome severity score.
Time Frame
baseline - 24 weeks
Title
Waist circumference (cm)
Description
This is a parameter for the calculation of metabolic syndrome severity score.
Time Frame
baseline - 24 weeks
Title
Serum triglyceride(mmol/L)
Description
This is a parameter for the calculation metabolic syndrome severity score.
Time Frame
baseline - 24 weeks
Title
Serum high density lipoprotein (HDL) (mmol/L)
Description
This is a parameter for the calculation metabolic syndrome severity score.
Time Frame
baseline - 24 weeks
Secondary Outcome Measure Information:
Title
Number of fasting hours per day
Description
For assessment of adherence
Time Frame
baseline - 24 weeks
Title
Number of days achieving TRF
Description
For assessment of adherence
Time Frame
baseline-24 weeks
Title
Incidence of treatment-emergent adverse events [Safety ]
Time Frame
baseline-24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-59 years of age BMI 27.5kg/m2 - 39.9kg/m2 Smart phone users Willing to lose weight Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. Exclusion Criteria: Those with history of cardiovascular disease, cerebrovascular accidents, degenerative or inflammatory diseases of the nervous system; epilepsy, malignancy, gastrointestinal disorders, thyroid disorders, diabetes or medications which could have had metabolic effects. Women who are pregnant or breastfeeding. Those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months. Subjects with any medical condition, which in the investigator's judgment may be associated with increased risk to the subject or may interfere with study assessments or outcomes. Those currently on medication for chronic illness. Permanent night shift worker Those who need to practise Ramadan fasting during the period of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kooi Yau Chean
Organizational Affiliation
RCSI & UCD Malaysia Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penang General Hospital
City
George Town
State/Province
Penang
ZIP/Postal Code
10450
Country
Malaysia

12. IPD Sharing Statement

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Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

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