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

Not Applicable

• Conditions: Sickle Cell Anemia
• Interventions: Behavioral: Resistance exercise; Dietary Supplement: placebo; Dietary Supplement: β-hydroxy-β-methylbutyrate

• Registration Number: NCT04001907
• Lead Sponsor: The University of The West Indies

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 Timeline

• Study Start: 2013-04-30
• Primary Completion: 2017-03-07
• Status Verified: 2019-03
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Study First Posted: 2019-06-28
• Last Update Posted: 2019-06-28
• Study Completion: 2019-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• BMI < 18.5 kg/m2

Exclusion Criteria

• BMI > 19 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise combined with placebo	placebo	Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
exercise combined with β-hydroxy-β-methylbutyrate (HMB)	Resistance exercise	Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
exercise combined with β-hydroxy-β-methylbutyrate (HMB)	β-hydroxy-β-methylbutyrate	Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
exercise combined with placebo	Resistance exercise	Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks

Primary Outcome Measures

Name	Time	Method
Body composition assessment using deuterium dilution method	3 months	Change between baseline and after 3 months of intervention
Body composition assessment using Dual-energy X-ray absorptiometry	3 months	Change between baseline and after 3 months of intervention
Body composition assessment using bioelectrical impedance	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)	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	3 months	Change between baseline and after 3 months of intervention

Secondary Outcome Measures

Name	Time	Method
Dietary intake using three 24 h dietary recall before and after intervention	30 min	Change between baseline and after 3 months of intervention
Resting metabolic rate using indirect calorimetry before and after intervention	30 min	Change between baseline and after 3 months of intervention