Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04001907
Enrollment
24
Registered
2019-06-28
Start date
2013-04-30
Completion date
2019-11-15
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia

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.

Interventions

BEHAVIORALResistance exercise

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

DIETARY_SUPPLEMENTplacebo

Sponsors

The University of The West Indies
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* BMI \< 18.5 kg/m2

Exclusion criteria

* BMI \> 19 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Body composition assessment using Dual-energy X-ray absorptiometry3 monthsChange between baseline and after 3 months of intervention
Body composition assessment using deuterium dilution method3 monthsChange 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 monthsChange between baseline and after 3 months of intervention
Body composition assessment using bioelectrical impedance3 monthsChange 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 phenylalanine3 monthsChange between baseline and after 3 months of intervention

Secondary

MeasureTime frameDescription
Resting metabolic rate using indirect calorimetry before and after intervention30 minChange between baseline and after 3 months of intervention
Dietary intake using three 24 h dietary recall before and after intervention30 minChange between baseline and after 3 months of intervention

Other

MeasureTime frameDescription
Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count)3 monthsThree measurements at baseline, mid point of intervention and at end of intervention
Number of participants with intervention-related adverse health effect as assessed by completing a health-related questionnaireweekly for 3 monthsAssessment at baseline and at the end of each week during the intervention
Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaireweekly for 3 monthsAssessment at baseline and at the end of each week during the intervention
Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile)3 monthsThree measurements at baseline, mid point of intervention and at end of intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026