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

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ClinicalTrials.gov Identifier: NCT02606669
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Benjamin Lam, Khoo Teck Puat Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Fasting Dietary Supplement: Meal Replacement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects: a Pilot Randomized Control Trial
Study Start Date : December 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Intermittent Fasting
The intervention of interest here is the Intermittent Energy Restriction (IER) or the Intermittent Fasting approach, specifically, the "5:2" diet, where adherence to this dietary intervention consists of fasting for two consecutive days and consuming enough to meet energy requirements for the remaining five non-fasting days. In this study, fasting will be achieved by using a meal replacement product (Optifast®) supplemented by two scoops of protein powder (Propass®) and a multivitamin, making a total of 540kcal (54g protein, 60g carbohydrates) for each fasting day.
Dietary Supplement: Meal Replacement
Using a Meal Replacement product, supplemented by protein powder and multivitamin

No Intervention: Control
Diet and Physical Activity advice only. No treatment plan.



Primary Outcome Measures :
  1. Change in Total Body Weight (in kg) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]

Secondary Outcome Measures :
  1. Change in Quality of Life (as determined by RAND Short Form-36 health survey) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  2. Change in Insulin Sensitivity % (as determined by the Homeostasis Model Assessment (HOMA)) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  3. Change in Total Cholesterol levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  4. Change in Low Density Lipoprotein (LDL)- Cholesterol levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  5. Change in High Density Lipoprotein (HDL)-Cholesterol levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  6. Change in Triglyceride levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  7. Change in Waist Circumference (in cm) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  8. Change in Body Fat % (as determined by bio-electrical impedance analysis) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  9. Change in Hip circumference (in cm) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  10. Change in Alanine transaminase (ALT) levels (in U/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  11. Change in Aspartate aminotransferase (AST) levels (in U/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
  12. Change in Gamma-glutamyl transpeptidase (GGT) levels (in U/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to provide informed consent.
  • Chinese. (Both parents must be Chinese)
  • Age above 21 years old. This study will focus only on adult subjects, and 21 years old is chosen as the age cut off, as it is the recognised legal age of independent consent.
  • BMI ≥ 25 kg/m2

Exclusion Criteria:

  • Pregnant, or any possibility of being pregnant (based on last menstrual period).
  • Lactation.
  • Age above 70 years old and/or suffering from cancer, diabetes, or any major cardiovascular disease, respiratory, psychiatric or musculoskeletal morbidity.
  • Currently dieting or losing weight
  • Unable to tolerate or complete two consecutive days of fasting during a two-day trial before recruitment.
  • Unwilling to be randomised into intervention or control group.

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): NCT02606669


Locations
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Singapore
Khoo Teck Puat Hospital
Singapore, Singapore, 768828
Sponsors and Collaborators
Khoo Teck Puat Hospital
Investigators
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Principal Investigator: Benjamin Lam, MBBS, MMed Khoo Teck Puat Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benjamin Lam, Consultant, Department of Family and Community Medicine, Khoo Teck Puat Hospital, Khoo Teck Puat Hospital
ClinicalTrials.gov Identifier: NCT02606669    
Other Study ID Numbers: 2015/00815
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Overweight
Body Weight