Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243746
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Chean Kooi Yau, RCSI & UCD Malaysia Campus

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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Pre Diabetes Behavioral: Time Restricted Feeding Behavioral: Standard Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)
Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).
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.

Active Comparator: Standard Malaysian Healthy Plate (QQH)
Subjects practise the QQH dietary plan.
Behavioral: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243746


Contacts
Layout table for location contacts
Contact: Kooi Yau Chean +6042171999 ext 1923 kychean@rcsiucd.edu.my

Sponsors and Collaborators
RCSI & UCD Malaysia Campus
Investigators
Layout table for investigator information
Principal Investigator: Kooi Yau Chean RCSI & UCD Malaysia Campus
Layout table for additonal information
Responsible Party: Dr Chean Kooi Yau, Principal investigator, senior lecturer, RCSI & UCD Malaysia Campus
ClinicalTrials.gov Identifier: NCT04243746    
Other Study ID Numbers: TRF168 001
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Prediabetic State
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases