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The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects

NCT02606669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-08-22

No results posted yet for this study

Summary

Background and Aims: The "5:2 diet", a form of intermittent energy restriction, has been popularized in Europe and USA. The rationale behind this approach is that two days of dieting is potentially more achievable, yet long enough to reduce overall weekly energy intake. However, this specific approach is lacking in evidence. Therefore, we are keen to investigate the effectiveness of this form of intermittent energy restriction compared with a control intervention (providing dietary and exercise advice only), in overweight, Chinese subjects, for an intervention period of 12 weeks.

Design and Methods: This will be a randomized controlled trial, with 15 subjects in each arm, for an intervention period of 12 weeks. Subjects randomized to the treatment group will take three packets of a meal replacement product (Optifast®) per day during two consecutive fasting days, and take a healthy balanced diet that meet estimated energy requirements for the remaining five days. Subjects randomized to the control group will be given general diet advice and allowed to eat ad libitum throughout the study period. Measurements and laboratory tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary interventions will be assessed at 4 weeks and 12 weeks using 7-day food diaries.

Significance: This will be the first study looking at an Asian population and will serve as a pilot towards a larger randomized trial. If this approach is found to be safe, effective and easier to adhere compared to the traditional continuous energy restriction, then it will be a very valuable option in the treatment of obesity, which has become an increasing problem globally including Singapore.

Conditions

Interventions

DIETARY_SUPPLEMENT

Meal Replacement

Using a Meal Replacement product, supplemented by protein powder and multivitamin

Sponsors & Collaborators

  • Khoo Teck Puat Hospital

    lead OTHER

Principal Investigators

  • Benjamin Lam, MBBS, MMed · Khoo Teck Puat Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02606669 on ClinicalTrials.gov