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出境医 / 临床实验 / Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia

Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Behavioral: Resistance exercise Dietary Supplement: β-hydroxy-β-methylbutyrate Dietary Supplement: placebo Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 30, 2013
Actual Primary Completion Date : March 7, 2017
Estimated Study Completion Date : November 15, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: exercise combined with β-hydroxy-β-methylbutyrate (HMB)
Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
 Behavioral: Resistance exercise
effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
Other Name: HMB

Dietary Supplement: β-hydroxy-β-methylbutyrate
Placebo Comparator: exercise combined with placebo
Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
 Behavioral: Resistance exercise
effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
Other Name: HMB

Dietary Supplement: placebo
Other Name: maltodextrin
Outcome Measures
Primary Outcome Measures :
  1. Body composition assessment using deuterium dilution method [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  2. Body composition assessment using Dual-energy X-ray absorptiometry [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  3. Body composition assessment using bioelectrical impedance [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  4. 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) [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  5. Protein oxidation using established stable isotope tracer method with oral doses of isotopically labelled sodium bicarbonate and phenylalanine [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention


Secondary Outcome Measures :
  1. Dietary intake using three 24 h dietary recall before and after intervention [ Time Frame: 30 min ]
    Change between baseline and after 3 months of intervention

  2. Resting metabolic rate using indirect calorimetry before and after intervention [ Time Frame: 30 min ]
    Change between baseline and after 3 months of intervention


Other Outcome Measures:
  1. Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count) [ Time Frame: 3 months ]
    Three measurements at baseline, mid point of intervention and at end of intervention

  2. Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile) [ Time Frame: 3 months ]
    Three measurements at baseline, mid point of intervention and at end of intervention

  3. Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaire [ Time Frame: weekly for 3 months ]
    Assessment at baseline and at the end of each week during the intervention

  4. Number of participants with intervention-related adverse health effect as assessed by completing a health-related questionnaire [ Time Frame: weekly for 3 months ]
    Assessment at baseline and at the end of each week during the intervention


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI < 18.5 kg/m2

Exclusion Criteria:

  • BMI > 19 kg/m2
Contacts and Locations

Sponsors and Collaborators
The University of The West Indies
Investigators
Layout table for investigator information
Principal Investigator: Asha V Badaloo, PhD Tropical Metabolism Research Unit, CAIHR, University of the West Indies
Study Director: Marvin E Reid, MBBS, PhD Tropical Metabolism Research Unit, CAIHR, University of the West Indies
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE April 30, 2013
Actual Primary Completion Date March 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Body composition assessment using deuterium dilution method [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention
  • Body composition assessment using Dual-energy X-ray absorptiometry [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention
  • Body composition assessment using bioelectrical impedance [ Time Frame: 3 months ]
    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) [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Dietary intake using three 24 h dietary recall before and after intervention [ Time Frame: 30 min ]
    Change between baseline and after 3 months of intervention
  • Resting metabolic rate using indirect calorimetry before and after intervention [ Time Frame: 30 min ]
    Change between baseline and after 3 months of intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2019)
  • Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count) [ Time Frame: 3 months ]
    Three measurements at baseline, mid point of intervention and at end of intervention
  • Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile) [ Time Frame: 3 months ]
    Three measurements at baseline, mid point of intervention and at end of intervention
  • Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaire [ Time Frame: weekly for 3 months ]
    Assessment at baseline and at the end of each week during the intervention
  • Number of participants with intervention-related adverse health effect as assessed by completing a health-related questionnaire [ Time Frame: weekly for 3 months ]
    Assessment at baseline and at the end of each week during the intervention
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia
Official Title  ICMJE Effects of β-hydroxy-β-methyl Butyrate Supplementation and Resistance Exercise on Body Composition, Muscle Strength and Protein Oxidation in Sickle Cell Anaemia.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Anemia
Intervention  ICMJE
  • Behavioral: Resistance exercise
    effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
    Other Name: HMB
  • Dietary Supplement: β-hydroxy-β-methylbutyrate
  • Dietary Supplement: placebo
    Other Name: maltodextrin
Study Arms  ICMJE
  • Experimental: exercise combined with β-hydroxy-β-methylbutyrate (HMB)
    Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
    Interventions:
    • Behavioral: Resistance exercise
    • Dietary Supplement: β-hydroxy-β-methylbutyrate
  • Placebo Comparator: exercise combined with placebo
    Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
    Interventions:
    • Behavioral: Resistance exercise
    • Dietary Supplement: placebo
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Borack MS, Volpi E. Efficacy and Safety of Leucine Supplementation in the Elderly. J Nutr. 2016 Dec;146(12):2625S-2629S. Epub 2016 Nov 9. Review.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2019
Actual Primary Completion Date March 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI < 18.5 kg/m2

Exclusion Criteria:

  • BMI > 19 kg/m2
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001907
Other Study ID Numbers  ICMJE HMB001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of The West Indies
Study Sponsor  ICMJE The University of The West Indies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asha V Badaloo, PhD Tropical Metabolism Research Unit, CAIHR, University of the West Indies
Study Director: Marvin E Reid, MBBS, PhD Tropical Metabolism Research Unit, CAIHR, University of the West Indies
PRS Account The University of The West Indies
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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