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

NCT04001907 | Unknown DMC

• 1 other identifier: HMB001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (5)

• Body composition assessment using deuterium dilution method

  Change between baseline and after 3 months of intervention

  3 months

• Body composition assessment using Dual-energy X-ray absorptiometry

  Change between baseline and after 3 months of intervention

  3 months

• Body composition assessment using bioelectrical impedance

  Change between baseline and after 3 months of intervention

  3 months

• 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

  3 months

• 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

  3 months

Secondary Outcomes (2)

• Dietary intake using three 24 h dietary recall before and after intervention

  30 min

• Resting metabolic rate using indirect calorimetry before and after intervention

  30 min

Other Outcomes (4)

• Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count)

  3 months

• Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile)

  3 months

• Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaire

  weekly for 3 months

Study Arms (2)

exercise combined with β-hydroxy-β-methylbutyrate (HMB)

EXPERIMENTAL

Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks

Behavioral: Resistance exercise; Dietary Supplement: β-hydroxy-β-methylbutyrate

exercise combined with placebo

PLACEBO COMPARATOR

Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks

Behavioral: Resistance exercise; Dietary Supplement: placebo

Interventions

Resistance exercise BEHAVIORAL

effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.

Also known as: HMB

exercise combined with placebo; exercise combined with β-hydroxy-β-methylbutyrate (HMB)

β-hydroxy-β-methylbutyrate DIETARY_SUPPLEMENT

exercise combined with β-hydroxy-β-methylbutyrate (HMB)

placebo DIETARY_SUPPLEMENT

Also known as: maltodextrin

exercise combined with placebo

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \< 18.5 kg/m2

You may not qualify if:

• BMI \> 19 kg/m2

Sponsors & Collaborators

• The University of The West Indies: lead

Related Publications (9)

• 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.

  PMID: 18173841 BACKGROUND

• 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.

  PMID: 2758764 BACKGROUND

• 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.

  PMID: 3409857 BACKGROUND

• 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.

  PMID: 15080599 BACKGROUND

• 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.

  PMID: 8941534 BACKGROUND

• 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.

  PMID: 27934654 BACKGROUND

• 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.

  PMID: 28554316 BACKGROUND

• 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.

  PMID: 2858749 BACKGROUND

• 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.

  PMID: 11722957 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Resistance Training; maltodextrin

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Asha V Badaloo, PhD

  Tropical Metabolism Research Unit, CAIHR, University of the West Indies

  PRINCIPAL INVESTIGATOR

• Marvin E Reid, MBBS, PhD

  Tropical Metabolism Research Unit, CAIHR, University of the West Indies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: June 28, 2019
• Study Start: April 30, 2013
• Primary Completion: March 7, 2017
• Study Completion: November 15, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share