Effect of β-Hydroxy-β-Methylbutyrate Supplementation Combined With the Vivifrail Multicomponent Exercise Program on Body Composition, Handgrip Strength and Functional Physical Performance in Women Over 60 Years of Age in Tulancingo de Bravo, Hidalgo: A Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor study identifier
interventional
44
1 country
1
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in handgrip strength
Maximum handgrip strength (kg) measured with a Jamar hydraulic dynamometer. Higher values indicate greater muscle strength.
Baseline, week 6 and week 12
Change in Short Physical Performance Battery (SPPB) score
Baseline, week 6 and week 12
Change in appendicular muscle mass
Baseline, week 6 and week 12
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.
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.
3 g/day orally for 12 weeks (Nutricost), supplied in sachets.
Maltodextrin without HMB (Nutricost), same dose schedule and identical sachet presentation as HMB-Ca, for 12 weeks.
Casa Club de la Tercera Edad, Sistema DIF Tulancingo
Tulancingo, Hidalgo, 43600, Mexico
Rodrigo Ronces Arrieta, BSc
Universidad Autónoma del Estado de Hidalgo
Trinidad Lorena Fernández Cortés, MSc
Universidad Autónoma del Estado de Hidalgo
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
December 2026
Change in body fat percentage
Baseline, week 6 and week 12
Change in calf circumference
Baseline, week 6 and week 12
Change in relaxed arm circumference
Baseline, week 6 and week 12
Dietary protein intake
Baseline, week 6 and week 12
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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Individual participant data will not be shared publicly to protect participant confidentiality, in accordance with the informed consent and Mexican personal data protection regulations.
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Source: ClinicalTrials.gov.
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