An interventional study of Calcium β-hydroxy-β-methylbutyrate (HMB-Ca) and Maltodextrin (Placebo) in Aging, Muscle Strength and Physical Functional Performance, sponsored by Universidad Autónoma del Estado de Hidalgo. Not yet recruiting at 1 site in Mexico. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Universidad Autónoma del Estado de Hidalgo · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn whether taking a daily supplement of β-hydroxy-β-methylbutyrate (HMB) while following a structured exercise program improves body composition, muscle strength and physical performance in older women. The main question it aims to answer is: does HMB (3 g per day) combined with the Vivifrail multicomponent exercise program improve handgrip strength more than the same exercise program combined with maltodextrin without HMB? Researchers will also compare body composition and physical performance between groups.
Participants will take the assigned supplement every day for 12 weeks, attend three supervised Vivifrail exercise sessions per week at the Casa Club de la Tercera Edad (DIF Tulancingo, Hidalgo, Mexico), and complete evaluations at baseline, week 6 and week 12.
Age-related loss of muscle strength and physical function is associated with disability, falls and loss of independence. Multicomponent exercise is the main recommended intervention, and HMB, a leucine metabolite, has been proposed to enhance its effects on skeletal muscle. This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will include women aged 60 to 80 years with a Short Physical Performance Battery (SPPB) score of 7 to 12, corresponding to Vivifrail exercise passports C (pre-frailty) and D (robustness).
Participants will be randomly assigned (1:1) using stratified block randomization generated with Research Randomizer, with allocation concealed in sealed opaque envelopes, to: (1) calcium HMB 3 g/day plus Vivifrail, or (2) maltodextrin without HMB plus Vivifrail, for 12 weeks. Both products (Nutricost) are supplied in identical sachets. The Vivifrail program is delivered in three supervised sessions per week, using Vivifrail passports C and D according to each participant's SPPB score. Participants, the exercise supervisor, the principal investigator and outcome assessors are blinded to group allocation.
The primary outcome is handgrip strength measured with a Jamar hydraulic dynamometer. Secondary outcomes include body composition by bioelectrical impedance (Tanita BC-545N), anthropometric circumferences (calf, waist, relaxed arm and flexed arm; ISAK protocol) and physical performance (SPPB). Physical activity level will be described with the International Physical Activity Questionnaire (IPAQ, short form). Dietary intake will be assessed with three multiple-pass 24-hour recalls at each time point, and protein intake will be used as a time-varying covariate. Women with type 2 diabetes or hypertension may participate if under treatment and controlled; blood pressure and capillary glucose will be monitored before exercise sessions according to predefined safety criteria. Data will be analyzed by intention-to-treat using linear mixed models with a group × time interaction.
Universidad Autónoma del Estado de Hidalgo is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 3 g/day of calcium β-hydroxy-β-methylbutyrate (Nutricost) for 12 weeks plus the Vivifrail multicomponent exercise program, three supervised sessions per week.
Dietary Supplement: Calcium β-hydroxy-β-methylbutyrate (HMB-Ca) · Behavioral: Vivifrail multicomponent exercise program
Participants receive maltodextrin without HMB (Nutricost), supplied in sachets identical to the HMB sachets, for 12 weeks plus the Vivifrail multicomponent exercise program, three supervised sessions per week.
Dietary Supplement: Maltodextrin (Placebo) · Behavioral: Vivifrail multicomponent exercise program
3 g/day orally for 12 weeks (Nutricost), supplied in sachets.
Also known as: HMB, beta-hydroxy-beta-methylbutyrate
Maltodextrin without HMB (Nutricost), same dose schedule and identical sachet presentation as HMB-Ca, for 12 weeks.
Multicomponent exercise (strength, power, balance, flexibility and walking) following Vivifrail passports C and D according to each participant's SPPB score, three supervised sessions per week for 12 weeks at the Casa Club de la Tercera Edad, DIF Tulancingo.
Also known as: Vivifrail
Change in handgrip strength
Maximum handgrip strength (kg) measured with a Jamar hydraulic dynamometer. Higher values indicate greater muscle strength.
Time frame: Baseline, week 6 and week 12
Change in Short Physical Performance Battery (SPPB) score
Total SPPB score (0-12 points), including balance, 4-meter gait speed and 5-times chair stand tests. Higher scores indicate better physical performance.
Time frame: Baseline, week 6 and week 12
Change in appendicular muscle mass
Appendicular muscle mass (kg), calculated as the sum of segmental muscle mass of both arms and both legs estimated by segmental bioelectrical impedance (Tanita BC-545N).
Time frame: Baseline, week 6 and week 12
Change in body fat percentage
Body fat (%) estimated by bioelectrical impedance (Tanita BC-545N).
Time frame: Baseline, week 6 and week 12
Change in calf circumference
Calf circumference (cm) measured following the ISAK protocol.
Time frame: Baseline, week 6 and week 12
Change in relaxed arm circumference
Relaxed arm circumference (cm) measured following the ISAK protocol.
Time frame: Baseline, week 6 and week 12
Change in flexed arm circumference
Flexed and tensed arm circumference (cm) measured following the ISAK protocol.
Time frame: Baseline, week 6 and week 12
Change in waist circumference
Waist circumference (cm) measured following the ISAK protocol.
Time frame: Baseline, week 6 and week 12
Dietary protein intake
Protein intake (g/kg/day) estimated from three multiple-pass 24-hour dietary recalls (two weekdays and one weekend day), analyzed with Nutrimind software; used as a covariate.
Time frame: Baseline, week 6 and week 12
Plan to share: No — Individual participant data will not be shared publicly to protect participant confidentiality, in accordance with the informed consent and Mexican personal data protection regulations.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Apr 2027, 4 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beta-hydroxyisovaleric acid
Universidad Autónoma del Estado de Hidalgo