Comparison of Different Weight Loss Diets With Different Protein Content

NCT02277275 | Completed

• 1 other identifier: CIRG041
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

High-protein diets better preserve lean mass than conventional low-fat diets. However, they are costly and have potential health risks. Preserving lean mass is important for sustaining high resting energy expenditure, leading to greater initial weight loss, better weight maintenance and improving blood sugar levels. Branched-chain amino acids (BCAA) supplements are known to preserve lean mass but their effects during weight loss have not been examined. Investigators want to investigate if a BCAA-supplemented diet is more effective than a standard hypocaloric diet in terms of the aforementioned benefits, and yet has less detrimental effects than a high-protein diet for weight loss. Using a 16-week weight loss and 8-week weight maintenance intervention, overweight and obese men and women will be randomized to either a hypocaloric diet with BCAA or placebo supplements or a high-protein diet with placebo supplements. Participants' compliance to the diet versus supplements will be compared. Body composition, resting and diet-induced energy expenditure, insulin sensitivity will be measured and blood samples taken before and after weight loss. These findings will inform on the benefits of BCAA-supplementation during energy restriction and may offer an alternative cost-effective strategy for weight loss and maintenance, without the adverse health effects of a high-protein load.

Conditions

Weight Loss; Insulin Resistance

Keywords

Branched chain amino acid, high protein diet, weight loss

Outcome Measures

Primary Outcomes (1)

• Changes in body compostion(i.e muscle mass, fat mass) by DEXA scan measurements

  lean mass, fat mass

  Week 0, 16 and 24

Secondary Outcomes (3)

• Changes in resting and diet-induced energy expenditure

  Week 0, 16 and 24

• Changes in insulin resistance

  Week 0, 16 and 24

• inflammatory markers and gene expressions of PBMC

  week 0, 16, 24

Study Arms (3)

Standard protein diet with placebo

PLACEBO COMPARATOR

Subjects will be provided with standard protein diet for four months and corn starch pills(Placebo) for 6 months

Dietary Supplement: Placebo

Standard protein diet with BCAA

EXPERIMENTAL

Branched chain amino acid(BCAA) pills will be provided to subjects 0.15g/kg of body weight per day for six months, standard protein diet will be provided for four months

Dietary Supplement: BCAA

High protein diet with placebo

PLACEBO COMPARATOR

Subjects will be provided with high protein diet for four months and corn starch pills(Placebo) for 6 months

Dietary Supplement: Placebo

Interventions

BCAA DIETARY_SUPPLEMENT

Branched chain amino acid(BCAA) pills will be provided to subjects 0.15g/kg of body weight per day for six months

Also known as: AST BCAA 4500

Standard protein diet with BCAA

Placebo DIETARY_SUPPLEMENT

Placebo will be provided to the other two arms for six months

Also known as: Starch pill manufactured to mimic AST BCAA 4500

High protein diet with placebo; Standard protein diet with placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be willing and able to comply with study procedures and given written informed consent
• Chinese, aged 21-45 years old
• Body mass index (BMI) between 25 -35 kg/m2 and % body fat of more than 25 %.
• Sedentary adults, with \<1 episode of exercise per week
• Not have a history of food allergies or food intolerances
• Have maintained a stable body weight for at least 3 months prior to the study.
• Be a non-smoker
• Drinks less than 3 caffeinated beverages per day (coffee/tea/energy drinks)
• Drinks less than 3 units of alcohol per day

You may not qualify if:

• 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.
• Recent changes (gain or loss) in weight of \>5% over the past 3 months
• Significant changes in diet over the past 3 months
• Any use of weight-reduction drugs in the past 6 months
• Use of any prescription medication that cannot be safely discontinued within 14 days prior to study entry
• Have special dietary needs/restrictions e.g. vegetarian diet or unable to consume fish, seafood and beef
• History of eating disorders or irregular eating habits
• High level of physical activity (exercise \> 5hr per week)
• 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.
• Have contraindications to Magnetic Resonance Imaging (MRI) that includes metallic implants, pacemakers or stimulators, or any other methodology applied in the study.
• Have been involved in any clinical or food study within the preceding month.
• Presently consuming amino acid or protein-related supplements.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Clinical Nutrition Research Center

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Weight Loss; Insulin Resistance

Interventions

Starch

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Yung Seng Lee

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 28, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: July 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)