Obesity Clinical Trial
Official title:
The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects: a Pilot Randomized Control Trial
Verified date | August 2017 |
Source | Khoo Teck Puat Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Khoo Teck Puat Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Khoo Teck Puat Hospital |
Singapore,
Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16. — View Citation
Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Total Body Weight (in kg) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Quality of Life (as determined by RAND Short Form-36 health survey) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Insulin Sensitivity % (as determined by the Homeostasis Model Assessment (HOMA)) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Total Cholesterol levels (in mmol/L) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Low Density Lipoprotein (LDL)- Cholesterol levels (in mmol/L) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in High Density Lipoprotein (HDL)-Cholesterol levels (in mmol/L) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Triglyceride levels (in mmol/L) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Waist Circumference (in cm) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Body Fat % (as determined by bio-electrical impedance analysis) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Hip circumference (in cm) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Alanine transaminase (ALT) levels (in U/L) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Aspartate aminotransferase (AST) levels (in U/L) at 3 months compared to baseline | Baseline to 3 months | ||
Secondary | Change in Gamma-glutamyl transpeptidase (GGT) levels (in U/L) at 3 months compared to baseline | Baseline to 3 months |
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