We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001907
Recruitment Status : Unknown
Verified March 2019 by The University of The West Indies.
Recruitment status was:  Active, not recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
The University of The West Indies

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Behavioral: Resistance exercise Dietary Supplement: β-hydroxy-β-methylbutyrate Dietary Supplement: placebo Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 30, 2013
Actual Primary Completion Date : March 7, 2017
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: exercise combined with β-hydroxy-β-methylbutyrate (HMB)
Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks
 Behavioral: Resistance exercise
effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
Other Name: HMB

Dietary Supplement: β-hydroxy-β-methylbutyrate
Placebo Comparator: exercise combined with placebo
Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks
 Behavioral: Resistance exercise
effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
Other Name: HMB

Dietary Supplement: placebo
Other Name: maltodextrin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Body composition assessment using deuterium dilution method [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  2. Body composition assessment using Dual-energy X-ray absorptiometry [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  3. Body composition assessment using bioelectrical impedance [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  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) [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention

  5. Protein oxidation using established stable isotope tracer method with oral doses of isotopically labelled sodium bicarbonate and phenylalanine [ Time Frame: 3 months ]
    Change between baseline and after 3 months of intervention


Secondary Outcome Measures :
  1. Dietary intake using three 24 h dietary recall before and after intervention [ Time Frame: 30 min ]
    Change between baseline and after 3 months of intervention

  2. Resting metabolic rate using indirect calorimetry before and after intervention [ Time Frame: 30 min ]
    Change between baseline and after 3 months of intervention


Other Outcome Measures:
  1. Number of participants with intervention-related abnormal laboratory values as assessed by blood haematology (anaemia profile,white blood cells count, platelet count) [ Time Frame: 3 months ]
    Three measurements at baseline, mid point of intervention and at end of intervention

  2. Number of participants with intervention-related abnormal laboratory values as assessed by blood chemistry (liver function and lipid profile) [ Time Frame: 3 months ]
    Three measurements at baseline, mid point of intervention and at end of intervention

  3. Number of participants with intervention-related adverse effect on emotional profile according to the Circumplex Test of emotion questionnaire [ Time Frame: weekly for 3 months ]
    Assessment at baseline and at the end of each week during the intervention

  4. Number of participants with intervention-related adverse health effect as assessed by completing a health-related questionnaire [ Time Frame: weekly for 3 months ]
    Assessment at baseline and at the end of each week during the intervention


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI < 18.5 kg/m2

Exclusion Criteria:

  • BMI > 19 kg/m2
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001907


Sponsors and Collaborators
The University of The West Indies
Investigators
Layout table for investigator information
Principal Investigator: Asha V Badaloo, PhD Tropical Metabolism Research Unit, CAIHR, University of the West Indies
Study Director: Marvin E Reid, MBBS, PhD Tropical Metabolism Research Unit, CAIHR, University of the West Indies
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: The University of The West Indies
ClinicalTrials.gov Identifier: NCT04001907    
Other Study ID Numbers: HMB001
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn