Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia
Primary Purpose
Sickle Cell Anemia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance exercise
β-hydroxy-β-methylbutyrate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Anemia
Eligibility Criteria
Inclusion Criteria:
- BMI < 18.5 kg/m2
Exclusion Criteria:
- BMI > 19 kg/m2
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
exercise combined with β-hydroxy-β-methylbutyrate (HMB)
exercise combined with placebo
Arm Description
Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
Outcomes
Primary Outcome Measures
Body composition assessment using deuterium dilution method
Change between baseline and after 3 months of intervention
Body composition assessment using Dual-energy X-ray absorptiometry
Change between baseline and after 3 months of intervention
Body composition assessment using bioelectrical impedance
Change between baseline and after 3 months of intervention
muscle strength assessment using the 1-repetition maximum method for the lower body (leg extension and or seated leg press) and upper body (bench press, bicep preacher curl)
Change between baseline and after 3 months of intervention
Protein oxidation using established stable isotope tracer method with oral doses of isotopically labelled sodium bicarbonate and phenylalanine
Change between baseline and after 3 months of intervention
Secondary Outcome Measures
Dietary intake using three 24 h dietary recall before and after intervention
Change between baseline and after 3 months of intervention
Resting metabolic rate using indirect calorimetry before and after intervention
Change between baseline and after 3 months of intervention
Full Information
NCT ID
NCT04001907
First Posted
April 4, 2019
Last Updated
June 26, 2019
Sponsor
The University of The West Indies
1. Study Identification
Unique Protocol Identification Number
NCT04001907
Brief Title
Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia
Official Title
Effects of β-hydroxy-β-methyl Butyrate Supplementation and Resistance Exercise on Body Composition, Muscle Strength and Protein Oxidation in Sickle Cell Anaemia.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2013 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
November 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of The West Indies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Wasting is a common and significant problem in sickle cell anaemia (SCA) that correlates with poorer clinical outcome such as frequent painful crises, acute chest syndrome and sub normal resistance to infection. Thus, improvement of nutritional status in SCA holds the potential of ameliorating the course of the disease. Elevated haemolysis and its effects are associated with hypermetabolism and have resulted in higher rates of protein breakdown and synthesis, and energy expenditure. Offering more food has not optimized nutritional status and metabolic performance in free-living patients with SCA. Moreover, appetite might be suppressed. Supplementation with β-hydroxy-β-methylbutyrate (HMB), which is produced in the body from leucine, has been shown to have inhibitory effect on protein breakdown and to promote lean tissue synthesis in humans with sarcopenia. Also, HMB has been implicated as an ergogenic tool to promote exercise performance and skeletal muscle hypertrophy. Therefore, the investigators hypothesize that in individuals with SCA, an intervention of resistance exercise with HMB supplement will have a greater enhancing effect on muscle mass and strength compared to receiving resistance exercise without HMB.
Detailed Description
The investigators aim to measure muscle strength, body composition and whole body protein oxidation in two groups of adults with SCA within one week before and after 9 weeks of intervention in a randomized, double blinded study. One group (n =12 ) will receive an intervention of resistance exercise and HMB supplement, and the other group (n=12) will receive resistance exercise and a placebo (maltodextrin). Participants will be assigned a study code and all information and samples will be stored under the assigned code.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise combined with β-hydroxy-β-methylbutyrate (HMB)
Arm Type
Experimental
Arm Description
Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
Arm Title
exercise combined with placebo
Arm Type
Placebo Comparator
Arm Description
Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise
Other Intervention Name(s)
HMB
Intervention Description
effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
Intervention Type
Dietary Supplement
Intervention Name(s)
β-hydroxy-β-methylbutyrate
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
maltodextrin
Primary Outcome Measure Information:
Title
Body composition assessment using deuterium dilution method
Description
Change between baseline and after 3 months of intervention
Time Frame
3 months
Title
Body composition assessment using Dual-energy X-ray absorptiometry
Description
Change between baseline and after 3 months of intervention
Time Frame
3 months
Title
Body composition assessment using bioelectrical impedance
Description
Change between baseline and after 3 months of intervention
Time Frame
3 months
Title
muscle strength assessment using the 1-repetition maximum method for the lower body (leg extension and or seated leg press) and upper body (bench press, bicep preacher curl)
Description
Change between baseline and after 3 months of intervention
Time Frame
3 months
Title
Protein oxidation using established stable isotope tracer method with oral doses of isotopically labelled sodium bicarbonate and phenylalanine
Description
Change between baseline and after 3 months of intervention
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Dietary intake using three 24 h dietary recall before and after intervention
Description
Change between baseline and after 3 months of intervention
Time Frame
30 min
Title
Resting metabolic rate using indirect calorimetry before and after intervention
Description
Change between baseline and after 3 months of intervention
Time Frame
30 min
Other Pre-specified Outcome Measures:
Title
Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count)
Description
Three measurements at baseline, mid point of intervention and at end of intervention
Time Frame
3 months
Title
Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile)
Description
Three measurements at baseline, mid point of intervention and at end of intervention
Time Frame
3 months
Title
Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaire
Description
Assessment at baseline and at the end of each week during the intervention
Time Frame
weekly for 3 months
Title
Number of participants with intervention-related adverse health effect as assessed by completing a health-related questionnaire
Description
Assessment at baseline and at the end of each week during the intervention
Time Frame
weekly for 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI < 18.5 kg/m2
Exclusion Criteria:
BMI > 19 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asha V Badaloo, PhD
Organizational Affiliation
Tropical Metabolism Research Unit, CAIHR, University of the West Indies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marvin E Reid, MBBS, PhD
Organizational Affiliation
Tropical Metabolism Research Unit, CAIHR, University of the West Indies
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18173841
Citation
Wilson GJ, Wilson JM, Manninen AH. Effects of beta-hydroxy-beta-methylbutyrate (HMB) on exercise performance and body composition across varying levels of age, sex, and training experience: A review. Nutr Metab (Lond). 2008 Jan 3;5:1. doi: 10.1186/1743-7075-5-1.
Results Reference
background
PubMed Identifier
2758764
Citation
Badaloo A, Jackson AA, Jahoor F. Whole body protein turnover and resting metabolic rate in homozygous sickle cell disease. Clin Sci (Lond). 1989 Jul;77(1):93-7. doi: 10.1042/cs0770093.
Results Reference
background
PubMed Identifier
3409857
Citation
Jackson AA, Landman JP, Stevens MC, Serjeant GR. Urea kinetics in adults with homozygous sickle cell disease. Eur J Clin Nutr. 1988 Jun;42(6):491-6.
Results Reference
background
PubMed Identifier
15080599
Citation
Rathmacher JA, Nissen S, Panton L, Clark RH, Eubanks May P, Barber AE, D'Olimpio J, Abumrad NN. Supplementation with a combination of beta-hydroxy-beta-methylbutyrate (HMB), arginine, and glutamine is safe and could improve hematological parameters. JPEN J Parenter Enteral Nutr. 2004 Mar-Apr;28(2):65-75. doi: 10.1177/014860710402800265.
Results Reference
background
PubMed Identifier
8941534
Citation
Nissen S, Sharp R, Ray M, Rathmacher JA, Rice D, Fuller JC Jr, Connelly AS, Abumrad N. Effect of leucine metabolite beta-hydroxy-beta-methylbutyrate on muscle metabolism during resistance-exercise training. J Appl Physiol (1985). 1996 Nov;81(5):2095-104. doi: 10.1152/jappl.1996.81.5.2095.
Results Reference
background
PubMed Identifier
27934654
Citation
Borack MS, Volpi E. Efficacy and Safety of Leucine Supplementation in the Elderly. J Nutr. 2016 Dec;146(12):2625S-2629S. doi: 10.3945/jn.116.230771. Epub 2016 Nov 9.
Results Reference
background
PubMed Identifier
28554316
Citation
Cruz-Jentoft AJ. Beta-Hydroxy-Beta-Methyl Butyrate (HMB): From Experimental Data to Clinical Evidence in Sarcopenia. Curr Protein Pept Sci. 2018;19(7):668-672. doi: 10.2174/1389203718666170529105026.
Results Reference
background
PubMed Identifier
2858749
Citation
Heyman MB, Vichinsky E, Katz R, Gaffield B, Hurst D, Castillo R, Chiu D, Kleman K, Ammann AJ, Thaler MM, et al. Growth retardation in sickle-cell disease treated by nutritional support. Lancet. 1985 Apr 20;1(8434):903-6. doi: 10.1016/s0140-6736(85)91677-0.
Results Reference
background
PubMed Identifier
11722957
Citation
Di Buono M, Wykes LJ, Ball RO, Pencharz PB. Dietary cysteine reduces the methionine requirement in men. Am J Clin Nutr. 2001 Dec;74(6):761-6. doi: 10.1093/ajcn/74.6.761.
Results Reference
background
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Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia
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