Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

NCT04243746 | Completed

• 1 other identifier: TRF168 001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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:

1. 1.Longer study duration of 6 months.
2. 2.This is the first study amongst the Asian population.
3. 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. 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.

Conditions

Obesity; Metabolic Syndrome; Pre Diabetes

Outcome Measures

Primary Outcomes (6)

• Body weight (kg)

  Mean body weight change will be calculated.

  baseline - 24 weeks

• Systolic BP (mmHg)

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

  baseline - 24 weeks

• Fasting blood sugar (mmol/L)

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

  baseline - 24 weeks

• Waist circumference (cm)

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

  baseline - 24 weeks

• Serum triglyceride(mmol/L)

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

  baseline - 24 weeks

• Serum high density lipoprotein (HDL) (mmol/L)

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

  baseline - 24 weeks

Secondary Outcomes (3)

• Number of fasting hours per day

  baseline - 24 weeks

• Number of days achieving TRF

  baseline-24 weeks

• Incidence of treatment-emergent adverse events [Safety ]

  baseline-24 weeks

Study Arms (2)

Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)

EXPERIMENTAL

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

Behavioral: Time Restricted Feeding

Standard Malaysian Healthy Plate (QQH)

ACTIVE COMPARATOR

Subjects practise the QQH dietary plan.

Behavioral: Standard Care

Interventions

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.

Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)

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.

Standard Malaysian Healthy Plate (QQH)

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RCSI & UCD Malaysia Campus: lead

Study Sites (1)

Penang General Hospital

George Town, Pulau Pinang, 10450, Malaysia

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Glucose Intolerance

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kooi Yau Chean

  RCSI & UCD Malaysia Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, senior lecturer

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 28, 2020
• Study Start: March 3, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

MY (1)