The effect of Sarcomeal® oral supplementation plus vitamin D3 on muscle parameters and metabolic factors in diabetic sarcopenia patients: study protocol of a randomized controlled clinical trial.

Background: Diabetes is a significant risk factor for sarcopenia, a muscle dystrophy affecting older individuals. Sarcopenia management typically involves resistance exercise and oral supplements. Given the limitations of resistance training for many elderly individuals, oral supplements play a crucial role in treatment. This study is a protocol for evaluating the efficacy of the Sarcomeal® supplement, a mixture of whey protein, creatine, branch-chained amino acids (BCAAs), glutamine, and hydroxyl-methyl-butyrate (HMB) in diabetic people who also have sarcopenia. METHODS AND ANALYSIS: This study is a randomized clinical trial, in which sixty diabetic sarcopenia patients who meet the inclusion criteria will be randomly assigned to the control or the intervention group with a 1:1 allocation. The intervention group will receive one Sarcomeal® supplement sachet plus 1000 IU of vitamin D daily and both groups will be recommended to consume protein-rich food, be educated about the disease, and perform light exercises for 12 weeks. Anthropometric measurements, body composition analysis, muscle strength assessments, and blood tests will be conducted at the trial's start and end.

Discussion: It is hypothesized that the Sarcomeal® supplement plus vitamin D may be beneficial for the management of diabetic sarcopenia by reducing inflammation, oxidative stress, and glucose metabolism. The outcome of this trial will provide a basis for prescribing sarcomeal to patients with diabetic sarcopenia.

Ethics and dissemination: This protocol is registered at the Iranian Registry of Clinical Trials (IRCT20230831059311N1) and also is approved by the ethics committee of Tehran University of Medical Sciences (September 2023, IR.TUMS.EMRI.REC.1402.071).

Trial registration: Iranian Registry of Clinical Trials (ID: IRCT20230831059311N1).