Comparison of Different Weight Loss Diets With Different Protein Content

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02277275
• Date of registration: 19/10/2014
• Prospective Registration: No
• Primary sponsor: National University, Singapore
• Public title: Comparison of Different Weight Loss Diets With Different Protein Content
• Scientific title: Effects of a BCAA-supplemented Hypocaloric Diet Versus a Standard Hypocaloric Diet on Weight Loss, Lean Mass Preservation and Improvement of Insulin Sensitivityand Its Benefits Over a High-protein Hypo-caloric Diet.
• Date of first enrolment: August 2014
• Target sample size: 109
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02277275
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Yung Seng Lee
• Affiliation: Associate Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Be willing and able to comply with study procedures and given written informed consent

2. Chinese, aged 21-45 years old

3. Body mass index (BMI) between 25 -35 kg/m2 and % body fat of more than 25 %.

4. Sedentary adults, with <1 episode of exercise per week

5. Not have a history of food allergies or food intolerances

6. Have maintained a stable body weight for at least 3 months prior to the study.

7. Be a non-smoker

8. Drinks less than 3 caffeinated beverages per day (coffee/tea/energy drinks)

9. Drinks less than 3 units of alcohol per day

Exclusion Criteria:

1. Subjects with diabetes, renal impairment, high blood pressure, gastrointestinal
problems, asthma, eczema, anaemia or on medications that will affect glucose
metabolism (e.g. corticosteroids) or lipid metabolism/insulin resistance (e.g. niacin,
fibrates, metformin) and other significant medical conditions, which in the
investigator's opinion would confound interpretation of results.

2. Recent changes (gain or loss) in weight of >5% over the past 3 months

3. Significant changes in diet over the past 3 months

4. Any use of weight-reduction drugs in the past 6 months

5. Use of any prescription medication that cannot be safely discontinued within 14 days
prior to study entry

6. Have special dietary needs/restrictions e.g. vegetarian diet or unable to consume
fish, seafood and beef

7. History of eating disorders or irregular eating habits

8. High level of physical activity (exercise > 5hr per week)

9. Women who are pregnant and lactating and women of reproductive age group who plan to
conceive within 6 months. A pregnancy test will be performed for women in the
reproductive age group.

10. Have contraindications to Magnetic Resonance Imaging (MRI) that includes metallic
implants, pacemakers or stimulators, or any other methodology applied in the study.

11. Have been involved in any clinical or food study within the preceding month.

12. Presently consuming amino acid or protein-related supplements.



Age minimum: 21 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Insulin Resistance

Weight Loss

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: BCAA

Primary Outcome(s)

Changes in body compostion(i.e muscle mass, fat mass) by DEXA scan measurements [Time Frame: Week 0, 16 and 24]

Secondary Outcome(s)

inflammatory markers and gene expressions of PBMC [Time Frame: week 0, 16, 24]

Changes in insulin resistance [Time Frame: Week 0, 16 and 24]

Changes in resting and diet-induced energy expenditure [Time Frame: Week 0, 16 and 24]

Secondary ID(s)

CIRG041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors