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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of β-hydroxy-β-methyl Butyrate Supplementation and Resistance Exercise on Body Composition, Muscle Strength and Protein Oxidation in Sickle Cell Anaemia.

Conditions
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Sickle Cell Anemia

Intervention / Treatment
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* Behavioral: Resistance exercise
* Dietary Supplement: β-hydroxy-β-methylbutyrate
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI < 18.5 kg/m2 Exclusion Criteria: BMI > 19 kg/m2

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise combined with β-hydroxy-β-methylbutyrate (HMB)<br>Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks | Behavioral: Resistance exercise<br>* effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.<br>* Other names: HMB;Dietary Supplement: β-hydroxy-β-methylbutyrate<br> <br> |
| Placebo Comparator: exercise combined with placebo<br>Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks | Behavioral: Resistance exercise<br>* effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.<br>* Other names: HMB;Dietary Supplement: placebo<br> <br> * Other names: maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake using three 24 h dietary recall before and after intervention | Change between baseline and after 3 months of intervention | 30 min | 
| Resting metabolic rate using indirect calorimetry before and after intervention | Change between baseline and after 3 months of intervention | 30 min |