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

The aim of current study is evaluation of the efficacy of 12-week yogurt fortified with beta-Hydroxy beta-Methyl Butyrate (HMB), vitamin D, and C on fat-free mass, muscle strength, and physical performance in older adults with sarcopenia.

In this research, a total of 60 eligible sarcopenic elderly people participate in a 12-week randomized, double-blind, placebo-controlled clinical trial. The active group (n=30) receive a yogurt fortified with HMB, vitamin D and C to consume daily for 12 weeks. The control group (n=30) receive iso-caloric control yogurt to consume daily for 12 weeks. In this study, we examine body composition with dual-energy X-ray absorptiometry (DXA) and Bioelectrical Impedance Analysis (BIA), muscle strength with handgrip dynamometer, and blood biochemical indexes of nutritional and health status, and evaluate nutritional status, physical function, and quality of life before and after the 12-week intervention.

Recruitment and initial assessment will be carried out in the 6 medical centers at Shiraz city. Sarcopenia assessment will be performed in Hormone Laboratory and Bone Densitometry Department, Namazi Hospital.

Participants are eligible to participate if they are diagnosed with sarcopenia according to EWGSOP guidelines. Subjects are not invited if they have comorbidities such as kidney or liver failure, malignancies, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disorder (COPD), or/and are using medications interfering with nutritional intervention such as steroids, heparin, free amino acid, antioxidant, omega-3, vitamin D supplements. Participant are excluded if they are unwillingness to continue the study.

Participants in case group consume daily 400 grams pre-packaged yogurt fortified with HMB, Vitamin D, and C and control group consume 400 grams per day pre-packaged placebo yogurt that have no additional ingredients.

Skeletal Muscle mass Index (SMI); Hand Grip Strength (HGS), Physical performance; anthropometric indices; biochemical parameters; nutritional status; physical activity and quality of Life.

Individuals will be classified into placebo and target groups with block randomization and Random allocation methods.

All participants in this study are unaware about their grouping because the package, label, and appearance of the target and placebo yogurt are quite similar. Since participants are not referred based on their group to clinical follow-up and outcome evaluator and he/she is also unaware of the separation of individuals. The principle investigators are not directly connected with the participants, so they are not aware of their grouping. An importer of data will also be outside the study system, which is generally unaware of the nature of the study.