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NCT Number: NCT04243746

Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

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.

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Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre Diabetes Signs and Symptoms

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penang General Hospital

George Town, Pulau Pinang, 10450, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time restricted feeding

Behavioral

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

Behavioral

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 outcomes

  1. Body weight (kg)

    Time frame: baseline - 24 weeks

    Mean body weight change will be calculated.

  2. Systolic BP (mmHg)

    Time frame: baseline - 24 weeks

    This is a parameter for the calculation of metabolic syndrome severity score.

  3. Fasting blood sugar (mmol/L)

    Time frame: baseline - 24 weeks

    This is a parameter for the calculation of metabolic syndrome severity score.

  4. Waist circumference (cm)

    Time frame: baseline - 24 weeks

    This is a parameter for the calculation of metabolic syndrome severity score.

  5. Serum triglyceride(mmol/L)

    Time frame: baseline - 24 weeks

    This is a parameter for the calculation metabolic syndrome severity score.

  6. Serum high density lipoprotein (HDL) (mmol/L)

    Time frame: baseline - 24 weeks

    This is a parameter for the calculation metabolic syndrome severity score.

Secondary outcomes

  1. Number of fasting hours per day

    Time frame: baseline - 24 weeks

    For assessment of adherence

  2. Number of days achieving TRF

    Time frame: baseline-24 weeks

    For assessment of adherence

  3. Incidence of treatment-emergent adverse events [Safety ]

    Time frame: baseline-24 weeks

Sponsors and collaborators

Lead sponsor

RCSI & UCD Malaysia Campus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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