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.
Study Goal
The researchers aimed to evaluate the efficacy of Sarcomeal® supplement combined with 1000 IU of vitamin D daily in managing diabetic sarcopenia by reducing inflammation, oxidative stress, and improving glucose metabolism.
Results Summary
The abstract does not provide results regarding Vitamin D's effects, as it describes a study protocol rather than outcomes.
Population
Diabetic sarcopenia patients (n=60).
Effective Dosage
1000 IU of vitamin D daily.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Sarcomeal® supplement plus vitamin D | decrease | diabetic sarcopenia | diabetic people who also have sarcopenia | - | may be beneficial for the management | #1 |
Sarcomeal® supplement plus vitamin D | decrease | inflammation | diabetic people who also have sarcopenia | - | reducing | #2 |
Sarcomeal® supplement plus vitamin D | decrease | oxidative stress | diabetic people who also have sarcopenia | - | reducing | #3 |
Sarcomeal® supplement plus vitamin D | decrease | glucose metabolism | diabetic people who also have sarcopenia | - | reducing | #4 |
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).