Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

Obesity Clinical Trial

Official title:

Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243746
• Other study ID #: TRF168 001
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2022
• Source: RCSI & UCD Malaysia Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. Longer study duration of 6 months.

2. This is the first study amongst the Asian population.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Pre Diabetes
• Prediabetic State
• Syndrome

Intervention

Behavioral:
• Time Restricted Feeding
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.
• Standard Care
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.

Locations

Country	Name	City	State
Malaysia	Penang General Hospital	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
RCSI & UCD Malaysia Campus

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (kg)	Mean body weight change will be calculated.	baseline - 24 weeks
Primary	Systolic BP (mmHg)	This is a parameter for the calculation of metabolic syndrome severity score.	baseline - 24 weeks
Primary	Fasting blood sugar (mmol/L)	This is a parameter for the calculation of metabolic syndrome severity score.	baseline - 24 weeks
Primary	Waist circumference (cm)	This is a parameter for the calculation of metabolic syndrome severity score.	baseline - 24 weeks
Primary	Serum triglyceride(mmol/L)	This is a parameter for the calculation metabolic syndrome severity score.	baseline - 24 weeks
Primary	Serum high density lipoprotein (HDL) (mmol/L)	This is a parameter for the calculation metabolic syndrome severity score.	baseline - 24 weeks
Secondary	Number of fasting hours per day	For assessment of adherence	baseline - 24 weeks
Secondary	Number of days achieving TRF	For assessment of adherence	baseline-24 weeks
Secondary	Incidence of treatment-emergent adverse events [Safety ]		baseline-24 weeks