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

Sickle Cell Anemia Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04001907
• Other study ID #: HMB001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 30, 2013
• Est. completion date: November 15, 2019

Study information

• Verified date: March 2019
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: November 15, 2019
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

Inclusion Criteria:

• BMI < 18.5 kg/m2

Exclusion Criteria:

• BMI > 19 kg/m2

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Anemia

Intervention

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

Dietary Supplement:
• ß-hydroxy-ß-methylbutyrate

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

References & Publications (9)

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. — View Citation

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count)	Three measurements at baseline, mid point of intervention and at end of intervention	3 months
Other	Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile)	Three measurements at baseline, mid point of intervention and at end of intervention	3 months
Other	Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaire	Assessment at baseline and at the end of each week during the intervention	weekly for 3 months
Other	Number of participants with intervention-related adverse health effect as assessed by completing a health-related questionnaire	Assessment at baseline and at the end of each week during the intervention	weekly for 3 months
Primary	Body composition assessment using deuterium dilution method	Change between baseline and after 3 months of intervention	3 months
Primary	Body composition assessment using Dual-energy X-ray absorptiometry	Change between baseline and after 3 months of intervention	3 months
Primary	Body composition assessment using bioelectrical impedance	Change between baseline and after 3 months of intervention	3 months
Primary	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
Primary	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	Dietary intake using three 24 h dietary recall before and after intervention	Change between baseline and after 3 months of intervention	30 min
Secondary	Resting metabolic rate using indirect calorimetry before and after intervention	Change between baseline and after 3 months of intervention	30 min