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Randomized Controlled Trial
. 2025 Mar 13;37(1):81.
doi: 10.1007/s40520-025-02969-x.

The efficacy of Sarcomeal® oral supplementation plus vitamin D3 on muscle parameters, metabolic factors, and quality of life in diabetic sarcopenia: a randomized controlled clinical trial

Ramin Abdi Dezfouli  1 , Narges Zargar Balajam  2 , Ramin Heshmat #  3 , Gita Shafiee #  4
Affiliations
Randomized Controlled Trial

The efficacy of Sarcomeal® oral supplementation plus vitamin D3 on muscle parameters, metabolic factors, and quality of life in diabetic sarcopenia: a randomized controlled clinical trial

Ramin Abdi Dezfouli et al. Aging Clin Exp Res. .

Abstract

Aim: To investigate the efficacy of Sarcomeal® sachet, as a protein supplement, plus vitamin D3 on muscle parameters, metabolic factors, and quality of life (QoL) in individuals with diabetes and sarcopenia.

Methods: Sixty individuals were randomized into the control or intervention group. The intervention group received a daily dose of one Sarcomeal sachet and 1000 IU of vitamin D and both groups were recommended to consume protein-rich food, be educated about the disease, and perform physical activity for 12 weeks. Various assessments including muscle parameters, blood tests, and QoL were conducted at the beginning and the end of the trial.

Results: Over 12 weeks, although the intervention group had significant improvements in mean skeletal muscle mass index (SMI) (change: 0.17[0.016, 0.329] kg/m²; p < 0.05) and handgrip strength (change: 1.33[0.256, 2.410] kg; p < 0.05), differences between groups were not statistically significant. However, significant improvements were observed in lean mass (1.70 [0.749, 2.665] kg; P < 0.01) and lean mass index (0.62[0.287, 0.954] kg/m2; P < 0.01) between groups. Weight was maintained in the intervention arm, whereas the control arm experienced significant weight loss (1.87 [0.654, 3.109] kg; P < 0.01). Participants in the intervention arm did not show significant changes in blood parameters. The most reported side effects were loss of appetite (50%) and stomach heaviness (20.8%).

Conclusion: This mixture of supplements significantly improved lean muscle mass, preserved physical function, and helped maintain weight, supporting its potential as a strategy to counter muscle loss and enhance the QoL in diabetic sarcopenia patients.

Clinical trial registration: This trial is registered at the Iranian Registry of Clinical Trials (IRCT) with IRCT20230831059311N1 ID.

Keywords: Intervention; Protein supplement; Quality of life; Sarcopenia; Type 2 diabetes; Vitamin D.

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Conflict of interest statement

Declarations. Ethical approval: This study is approved by the institutional ethics committee of the Endocrine and Metabolism Research Institute, Tehran University of Medical Sciences (IR.TUMS.EMRI.REC.1402.071). Consent to participate: All the patients included in this study provided written consent before they got involved in the study. All the participants’ personal data and information remain confidential. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
The flow diagram of participant screening, randomization, and follow-up
Fig. 2
Fig. 2
Percentage of change in each variable after a 12-week consumption of sarcomeal plus vitamin D
See this image and copyright information in PMC

References

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