Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Sarcopenia

Treatments: Dietary Supplement: whey protein; Dietary Supplement: symbiotic placebo; Dietary Supplement: whey protein placebo; Dietary Supplement: symbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06347835

Gut-Intervention-SAR-2024

Details and patient eligibility

About

The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia.

Full description

This study will last 12 weeks. For the duration of the study, an anticipated total of 120 participants will be randomly assigned to three groups. During the study visits, questionnaires, blood and stool collection, and functional testing will occur. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 65 and older
2. Can cooperate with the measurement and questionnaire survey
3. Meets Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria for sarcopenia
4. Obtain informed consent to participate in this study

Exclusion criteria

1. Severe complications
2. Suffers from neuromuscular related diseases
3. Immobility
4. Have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks
5. Implants of electronic devices or metal objects in the body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

symbiotic and whey protein intervention

Experimental group

Description:

This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks

Treatment:

Dietary Supplement: symbiotic

Dietary Supplement: whey protein

whey protein intervention

Experimental group

Description:

This group received dietary guidance and whey protein intervention for 12 weeks

Treatment:

Dietary Supplement: whey protein

Dietary Supplement: symbiotic placebo

control

Placebo Comparator group

Description:

This group received dietary guidance and maltodextrin for 12 weeks

Treatment:

Dietary Supplement: whey protein placebo

Dietary Supplement: symbiotic placebo