Clinical trial NCT04243746: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Pre Diabetes
Lead sponsor: RCSI & UCD Malaysia Campus
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body weight (kg)
timeFrame: baseline - 24 weeks
measure: Systolic BP (mmHg)
timeFrame: baseline - 24 weeks
measure: Fasting blood sugar (mmol/L)
timeFrame: baseline - 24 weeks
measure: Waist circumference (cm)
timeFrame: baseline - 24 weeks
measure: Serum triglyceride(mmol/L)
timeFrame: baseline - 24 weeks
measure: Serum high density lipoprotein (HDL) (mmol/L)
timeFrame: baseline - 24 weeks
Secondary outcomes:
measure: Number of fasting hours per day
timeFrame: baseline - 24 weeks
measure: Number of days achieving TRF
timeFrame: baseline-24 weeks
measure: Incidence of treatment-emergent adverse events [Safety ]
timeFrame: baseline-24 weeks
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Penang General Hospital
state: Penang
Study officials:
affiliation: RCSI & UCD Malaysia Campus
name: Kooi Yau Chean
role: PRINCIPAL_INVESTIGATOR
References: