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Sickle Cell AnemiaNCT04001907

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

A study testing Resistance exercise and β-hydroxy-β-methylbutyrate in people with Sickle Cell Anemia, run by The University of The West Indies.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 35 years
Conditions the study is for
Sickle Cell Anemia
What is being tested?
Resistance exercise and β-hydroxy-β-methylbutyrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
No sites listed yet
Study dates
30 Apr 2013to 15 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI < 18.5 kg/m2

Who cannot join

  • BMI > 19 kg/m2

About this study

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.

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.

Read the 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.

Being tested
Resistance exercise, β-hydroxy-β-methylbutyrate, placebo
Medical subject headings
Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance exerciseBehavioural

    Also called HMB

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

  • β-hydroxy-β-methylbutyrateDietary supplement

  • placeboDietary supplement

    Also called maltodextrin

Study groups in NCT04001907
Study groupRoleWhat they receive
exercise combined with β-hydroxy-β-methylbutyrate (HMB)ExperimentalResistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
Receives: Behavioral: Resistance exercise; Dietary Supplement: β-hydroxy-β-methylbutyrate
exercise combined with placeboPlacebo comparatorResistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
Receives: Behavioral: Resistance exercise; Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition assessment using deuterium dilution method

    Change between baseline and after 3 months of intervention

    Measured: 3 months

  2. Body composition assessment using Dual-energy X-ray absorptiometry

    Change between baseline and after 3 months of intervention

    Measured: 3 months

  3. Body composition assessment using bioelectrical impedance

    Change between baseline and after 3 months of intervention

    Measured: 3 months

  4. 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

    Measured: 3 months

  5. 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

    Measured: 3 months

Secondary outcomes (2)

  1. Dietary intake using three 24 h dietary recall before and after intervention

    Change between baseline and after 3 months of intervention

    Measured: 30 min

  2. Resting metabolic rate using indirect calorimetry before and after intervention

    Change between baseline and after 3 months of intervention

    Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2019
  2. Study start30 Apr 2013
  3. Primary completion7 Mar 2017
  4. Study completion15 Nov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04001907
Sponsor's protocol ID
HMB001
Status last verified
Mar 2019
First submitted
4 Apr 2019
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18173841

  • 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.

    PubMed 2758764

  • 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.

    PubMed 3409857

  • 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.

    PubMed 15080599

  • 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.

    PubMed 8941534

  • 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.

    PubMed 27934654

  • 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.

    PubMed 28554316

  • 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.

    PubMed 2858749

  • 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.

    PubMed 11722957

Questions about this trial

What is this clinical trial studying?

A study testing Resistance exercise and β-hydroxy-β-methylbutyrate in people with Sickle Cell Anemia, run by The University of The West Indies.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition assessment using deuterium dilution method (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04001907, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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