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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
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Anemia

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 4, 2019
    Last Updated
    June 26, 2019
    Sponsor
    The University of The West Indies
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    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
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    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
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    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
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    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
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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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