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

NCT02606669 | Completed

• 1 other identifier: 2015/00815
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Fasting

Outcome Measures

Primary Outcomes (1)

• Change in Total Body Weight (in kg) at 3 months compared to baseline

  Baseline to 3 months

Secondary Outcomes (12)

• Change in Quality of Life (as determined by RAND Short Form-36 health survey) at 3 months compared to baseline

  Baseline to 3 months

• Change in Insulin Sensitivity % (as determined by the Homeostasis Model Assessment (HOMA)) at 3 months compared to baseline

  Baseline to 3 months

• Change in Total Cholesterol levels (in mmol/L) at 3 months compared to baseline

  Baseline to 3 months

• Change in Low Density Lipoprotein (LDL)- Cholesterol levels (in mmol/L) at 3 months compared to baseline

  Baseline to 3 months

• Change in High Density Lipoprotein (HDL)-Cholesterol levels (in mmol/L) at 3 months compared to baseline

  Baseline to 3 months

Study Arms (2)

Intermittent Fasting

EXPERIMENTAL

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

Control

NO INTERVENTION

Diet and Physical Activity advice only. No treatment plan.

Interventions

Meal Replacement DIETARY_SUPPLEMENT

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

Intermittent Fasting

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khoo Teck Puat Hospital: lead

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (3)

• 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.

  PMID: 20921964 BACKGROUND

• 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.

  PMID: 23591120 BACKGROUND

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

  PMID: 33512717 DERIVED

MeSH Terms

Conditions

Obesity; Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Benjamin Lam, MBBS, MMed

  Khoo Teck Puat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Family and Community Medicine, Khoo Teck Puat Hospital

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

SG (1)