AgingNCT07905755
Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
A study testing Calcium β-hydroxy-β-methylbutyrate (HMB-Ca) and Vivifrail multicomponent exercise program in people with Aging and Muscle Strength, run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Muscle Strength, Physical Functional Performance
- What is being tested?
- Calcium β-hydroxy-β-methylbutyrate (HMB-Ca) and Vivifrail multicomponent exercise program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 60 to 80 years
- User of the Casa Club de la Tercera Edad, DIF Tulancingo, Hidalgo, Mexico
- Short Physical Performance Battery (SPPB) score of 7 to 12 points, corresponding to Vivifrail exercise passport C (pre-frailty, 7-9 points) or D (robustness, 10-12 points)
- Montreal Cognitive Assessment, Mexican Spanish version (MoCA-E), score of 24 or higher
- Women with type 2 diabetes or hypertension may participate only if under treatment and controlled
- Signed informed consent
Who cannot join
- Osteoarticular disease of the spine or limbs that contraindicates or prevents exercise (e.g., active rheumatoid arthritis)
- Heart failure or decompensated heart disease, or any medical contraindication to physical exercise
- Renal or hepatic failure
- Advanced cancer or cancer under active treatment
- Cognitive impairment preventing understanding of instructions, informed consent or test performance (MoCA-E score below 24 points)
- Pacemaker or other implanted electronic device (contraindication for bioelectrical impedance)
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- Clinically visible edema (interferes with bioelectrical impedance)
- Use of HMB, leucine, protein powder, creatine or other anabolic or ergogenic supplements in the 6 weeks before study start (washout period)
- Use of drugs affecting muscle mass or function (e.g., systemic corticosteroids or androgen therapy)
- Known allergy or intolerance to the components of the HMB supplement or the placebo (maltodextrin)
- Limb amputation or any condition preventing anthropometric or functional measurements
- Uncontrolled type 2 diabetes or hypertension, defined as urgent care or hospitalization for these conditions in the previous 3 months
- Current participation in a structured strength (resistance) training program outside the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Casa Club de la Tercera Edad, Sistema DIF Tulancingo
Tulancingo, Hidalgo, 43600
Rodrigo Ronces Arrieta, BSc, +52 7751458770, ro194886@uaeh.edu.mx
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Calcium β-hydroxy-β-methylbutyrate (HMB-Ca), Maltodextrin (Placebo), Vivifrail multicomponent exercise program
- Keywords
- beta-hydroxy-beta-methylbutyrate, HMB, dietary supplement, multicomponent exercise, Vivifrail, handgrip strength, Short Physical Performance Battery, older women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium β-hydroxy-β-methylbutyrate (HMB-Ca)Dietary supplement
Also called HMB, beta-hydroxy-beta-methylbutyrate
3 g/day orally for 12 weeks (Nutricost), supplied in sachets.
Maltodextrin (Placebo)Dietary supplement
Maltodextrin without HMB (Nutricost), same dose schedule and identical sachet presentation as HMB-Ca, for 12 weeks.
Vivifrail multicomponent exercise programBehavioural
Also called Vivifrail
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.
| Study group | Role | What they receive |
|---|---|---|
| HMB + Vivifrail | Experimental | 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. Receives: Dietary Supplement: Calcium β-hydroxy-β-methylbutyrate (HMB-Ca); Behavioral: Vivifrail multicomponent exercise program |
| Maltodextrin + Vivifrail | Placebo comparator | 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. Receives: Dietary Supplement: Maltodextrin (Placebo); Behavioral: Vivifrail multicomponent exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in handgrip strength
Maximum handgrip strength (kg) measured with a Jamar hydraulic dynamometer. Higher values indicate greater muscle strength.
Measured: Baseline, week 6 and week 12
Secondary outcomes (7)
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.
Measured: 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).
Measured: Baseline, week 6 and week 12
Change in body fat percentage
Body fat (%) estimated by bioelectrical impedance (Tanita BC-545N).
Measured: Baseline, week 6 and week 12
Change in calf circumference
Calf circumference (cm) measured following the ISAK protocol.
Measured: Baseline, week 6 and week 12
Change in relaxed arm circumference
Relaxed arm circumference (cm) measured following the ISAK protocol.
Measured: Baseline, week 6 and week 12
Change in flexed arm circumference
Flexed and tensed arm circumference (cm) measured following the ISAK protocol.
Measured: Baseline, week 6 and week 12
Change in waist circumference
Waist circumference (cm) measured following the ISAK protocol.
Measured: Baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, randomized controlled trial with 1:1 allocation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma del Estado de Hidalgo
- Sponsor type
- University, hospital or other
- Collaborators
- Sistema para el Desarrollo Integral de la Familia (DIF) de Tulancingo de Bravo
- Responsible party
- Principal investigator, Rodrigo Ronces Arrieta, Universidad Autónoma del Estado de Hidalgo
- Investigators
- Rodrigo Ronces Arrieta, BSc, Principal investigator, Universidad Autónoma del Estado de HidalgoTrinidad Lorena Fernández Cortés, MSc, Study director, Universidad Autónoma del Estado de Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905755
- Sponsor's protocol ID
- CEI-ICSa/248/2026
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07905755
- Acronym / sponsor ID
- CEI-ICSa/248/2026
- Keywords
- beta-hydroxy-beta-methylbutyrate, HMB, dietary supplement, multicomponent exercise, Vivifrail, handgrip strength, Short Physical Performance Battery, older women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad Autónoma del Estado de HidalgoUniversity, hospital or other
- Collaborators
- Sistema para el Desarrollo Integral de la Familia (DIF) de Tulancingo de Bravo
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized controlled trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| HMB + Vivifrail | Experimental | Dietary Supplement: Calcium β-hydroxy-β-methylbutyrate (HMB-Ca), Behavioral: Vivifrail multicomponent exercise programParticipants 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. |
| Maltodextrin + Vivifrail | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo), Behavioral: Vivifrail multicomponent exercise programParticipants 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 60 to 80 years
- User of the Casa Club de la Tercera Edad, DIF Tulancingo, Hidalgo, Mexico
- Short Physical Performance Battery (SPPB) score of 7 to 12 points, corresponding to Vivifrail exercise passport C (pre-frailty, 7-9 points) or D (robustness, 10-12 points)
- Montreal Cognitive Assessment, Mexican Spanish version (MoCA-E), score of 24 or higher
- Women with type 2 diabetes or hypertension may participate only if under treatment and controlled
Key exclusion criteria (13 listed)
- Osteoarticular disease of the spine or limbs that contraindicates or prevents exercise (e.g., active rheumatoid arthritis)
- Heart failure or decompensated heart disease, or any medical contraindication to physical exercise
- Renal or hepatic failure
- Advanced cancer or cancer under active treatment
- Cognitive impairment preventing understanding of instructions, informed consent or test performance (MoCA-E score below 24 points)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium β-hydroxy-β-methylbutyrate (HMB-Ca)Also: HMB, beta-hydroxy-beta-methylbutyrate3 g/day orally for 12 weeks (Nutricost), supplied in sachets. | Dietary supplement | HMB + Vivifrail |
| Maltodextrin (Placebo)Maltodextrin without HMB (Nutricost), same dose schedule and identical sachet presentation as HMB-Ca, for 12 weeks. | Dietary supplement | Maltodextrin + Vivifrail |
| Vivifrail multicomponent exercise programAlso: VivifrailMulticomponent 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. | Behavioural | HMB + Vivifrail, Maltodextrin + Vivifrail |
Primary outcome
Change in handgrip strength
Time frame: Baseline, week 6 and week 12
Maximum handgrip strength (kg) measured with a Jamar hydraulic dynamometer. Higher values indicate greater muscle strength.
7 secondary outcomes
Change in Short Physical Performance Battery (SPPB) score
Time frame: Baseline, week 6 and week 12
Change in appendicular muscle mass
Time frame: Baseline, week 6 and week 12
Change in body fat percentage
Time frame: Baseline, week 6 and week 12
Change in calf circumference
Time frame: Baseline, week 6 and week 12
Change in relaxed arm circumference
Time frame: Baseline, week 6 and week 12
Change in flexed arm circumference
Time frame: Baseline, week 6 and week 12
Change in waist circumference
Time frame: Baseline, week 6 and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo Ronces Arrieta, BSc principal investigator
Universidad Autónoma del Estado de Hidalgo
Trinidad Lorena Fernández Cortés, MSc study director
Universidad Autónoma del Estado de Hidalgo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium β-hydroxy-β-methylbutyrate (HMB-Ca) and Vivifrail multicomponent exercise program in people with Aging and Muscle Strength, run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Ronces Arrieta, BSc (+52 7751458770, ro194886@uaeh.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in handgrip strength (time frame: Baseline, week 6 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.