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Comparison of Different Weight Loss Diets With Different Protein Content

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277275
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Lee Yung Seng, National University, Singapore

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.

Condition or disease Intervention/treatment Phase
Weight Loss Insulin Resistance Dietary Supplement: BCAA Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official 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.
Actual Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard protein diet with placebo
Subjects will be provided with standard protein diet for four months and corn starch pills(Placebo) for 6 months
Dietary Supplement: Placebo
Placebo will be provided to the other two arms for six months
Other Name: Starch pill manufactured to mimic AST BCAA 4500

Experimental: Standard protein diet with BCAA
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
Branched chain amino acid(BCAA) pills will be provided to subjects 0.15g/kg of body weight per day for six months
Other Name: AST BCAA 4500

Placebo Comparator: High protein diet with placebo
Subjects will be provided with high protein diet for four months and corn starch pills(Placebo) for 6 months
Dietary Supplement: Placebo
Placebo will be provided to the other two arms for six months
Other Name: Starch pill manufactured to mimic AST BCAA 4500




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


Secondary Outcome Measures :
  1. Changes in resting and diet-induced energy expenditure [ Time Frame: Week 0, 16 and 24 ]
    Energy expenditure will be measured using indirect calorimetry before and after consuming the test meal

  2. Changes in insulin resistance [ Time Frame: Week 0, 16 and 24 ]
    Insulin sensitivity index can be derived from HOMA-IR and Masuda method

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


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02277275


Locations
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Singapore
Clinical Nutrition Research Center
Singapore, Singapore, 117599
Sponsors and Collaborators
National University, Singapore
Investigators
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Principal Investigator: Yung Seng Lee Associate Professor
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Responsible Party: Lee Yung Seng, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02277275    
Other Study ID Numbers: CIRG041
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lee Yung Seng, National University, Singapore:
Branched chain amino acid, high protein diet, weight loss
Additional relevant MeSH terms:
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Insulin Resistance
Body Weight
Weight Loss
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases