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Effect of Yogurt Fortified with beta-Hydroxy beta-Methyl Butyrate (HMB) in Sarcopenic Elderly

Evaluating the Effect of Yogurt Fortified with beta-Hydroxy beta-Methyl Butyrate (HMB), Vitamin D, and Vitamin C on Fat-Free Mass, Muscle Strength, and Physical Functionality in Sarcopenic Elderly

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171223038017N1
Enrollment
60
Registered
2018-01-09
Start date
2017-08-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia. Sarcopenia

Interventions

Intervention 1: Intervention group: receiving 400 grams per day of yogurt fortified with beta-hydroxy beta-butyl butyrate (HMB), vitamin D, and C for 12-week intervention that were produced by Zarrin
Rehabilitation
Placebo
Intervention group: receiving 400 grams per day of yogurt fortified with beta-hydroxy beta-butyl butyrate (HMB), vitamin D, and C for 12-week intervention that were produced by Zarrin Ghazal Industria
Control group: receiving 400 grams per day of placebo yogurt for 12-week intervention that were produced by Zarrin Ghazal Industrial Co. (Daity)

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor
Shiraz University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women aged 65 years and older Sarcopenia diagnosis according to European Working Group on Sarcopenia in Older People (EWGSOP) guidelines

Exclusion criteria

Exclusion criteria: Subjects unable to move without crutches, walker or other assistive devices. Subjects with artificial limbs. Subjects with history of chronic disease (e.g. Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disorder (COPD), Chronic Renal Failure (CRF), cirrhosis liver failure and active cancer). Subjects with history of kidney stones. Subjects who regularly consume any medications interfering with nutritional intervention (e.g. steroids, heparin, free amino acid, antioxidant, omega-3, vitamin D supplements).

Design outcomes

Primary

MeasureTime frame
Fat-free mass. Timepoint: Before and after intervention. Method of measurement: Dual energy X-ray Absorptiometry (DXA); Bioelectrical Impedance Analysis (BIA).

Secondary

MeasureTime frame
Hand grip. Timepoint: Before and after intervention. Method of measurement: Hydraulic Hand Dynamometer.;Physical performance (gait speed). Timepoint: Before and after intervention. Method of measurement: Stopwatch.;Physical activity. Timepoint: Before and after intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ).;Nutritional status. Timepoint: Before and after intervention. Method of measurement: Mini Nutritional Assessment (MNA) questionnaire.;Quality of life. Timepoint: Before and after intervention. Method of measurement: The Short Form Health Survey-12 (SF-12) questionnaire.;25- hydroxy vitamin D (25-OHD) level. Timepoint: Before and after intervention. Method of measurement: Chemiluminescence immunoassay (CLIA) method.;Albumin level. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Creatinine level. Timepoint: Before and after intervention. Method of measurement: Jaffe’s method.;C-Reactive Protein (hs-CRP) level. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Insulin-like Growth Factor – 1 (IGF-1). Timepoint: Before and after intervention. Method of measurement: Chemiluminescence immunoassay (CLIA) method.;Fasting Blood Sugar (FBS) level. Timepoint: Before and after intervention. Method of measurement: Auto analyser.;Fasting insulin level. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Malondialdehyde (MDA) level. Timepoint: Before and after intervention. Method of measurement: Spectrophotometry.;Blood urea nitrogen level. Timepoint: Before and after intervention. Method of measurement: Chemical Method (Diazine).;Lipid profile (LDL, HDL, Triglyceride, total Cholesterol). Timepoint: Before and after intervention. Method of measurement: Chemical Method (Kit).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Hossein Dabbaghmanesh

Shiraz University of Medical Sciences

dabbaghm@sums.ac.ir+98 71 3235 7282

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026