MedDataX Logo

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

NCT ID: NCT04001907

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2019-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sickle Cell Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Resistance exercise

Intervention Type BEHAVIORAL

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

β-hydroxy-β-methylbutyrate

Intervention Type DIETARY_SUPPLEMENT

exercise combined with placebo

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

Group Type PLACEBO_COMPARATOR

Resistance exercise

Intervention Type BEHAVIORAL

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

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance exercise

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

Intervention Type BEHAVIORAL

β-hydroxy-β-methylbutyrate

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HMB maltodextrin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI \< 18.5 kg/m2

Exclusion Criteria

* BMI \> 19 kg/m2
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Asha V Badaloo, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Marvin E Reid, MBBS, PhD

Role: STUDY_DIRECTOR

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

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18173841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2758764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3409857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15080599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8941534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27934654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28554316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2858749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11722957 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HMB001

Identifier Type: -

Identifier Source: org_study_id