Exercise, nutrition and muscle quality

Recruiting

Conditions: Obesity, unspecified,

Registration Number: CTRI/2019/06/019941

Lead Sponsor: Submitted to ICMR

Brief Summary: *Background:* Sarcopenia, an age related loss of skeletal muscle mass and functionis also seen in younger individuals and may lead to disability and futurecomplications. The trajectory of oneâ€™s muscle loss can be altered by physicalexercise and/or the environment, which are the modifiable risk factors.

*Novelty*: Indian population has been shown to have higher body fat and relativelylower quality and quantity of skeletal muscle mass which may increase risk of sarcopenia.This may contribute to the high prevalence of insulin resistance and itscomplications. Effective interventions for sarcopenia are likely to have impact onobesity and related metabolic problems. There is paucity of data in this regardin Indian population.

*Objectives*: To compare the effect of nutritional intervention along with progressiveresistance training and nutritional intervention along with standard physicalactivity on skeletal muscle mass and function, and metabolic parameters inobese sarcopenic individuals.

*Methods*: This randomized controlled trial will include 140 obese patients with sarcopeniadivided into two intervention arms (nutritional intervention with resistanceexercise vs. nutritional interventions with standard exercise) for a period of6 months. Anthropometry, biochemistry and muscle strength will be assessed atbaseline, 3 and 6 months. Whole body DEXA scan and plain CT scan at L3-4 levelfor skeletal muscle area will be done at baseline and at 6 months.

*Expected outcomes*: Combination of nutritional intervention along with progressiveresistance training is likely to improve skeletal muscle mass and function inobese sarcopenic individuals which may be helpful in designing appropriateinterventions for sarcopenia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 140

Inclusion Criteria

Individuals between 30-60 years of age with BMI â‰¥25 kg/m2, diagnosed to have sarcopenia based on the following definition of sarcopenia: 1 Appendicular skeletal muscle mass/height2: Men< 7.0 kg/m2, Women <6.0 kg/m2.
2 Hand grip strength Men: <27 kg Women: <16 kg 3 SPPB â‰¤8 (The maximum score on the SPPB is 12) 4 4-minute gait speed < 0.8 m/s.

Exclusion Criteria

1 Known or recently diagnosed diabetes mellitus or coronary heart disease 2 Contraindication to aerobic exercise or progressive resistance training 3 Any severe acute or chronic illness, severe end organ dysfunction, post organ transplant 4 Known malignancy, HIV/ HBsAg/Anti HCV positivity 5 Chronic alcohol use (>30 g/day in men and >20 g/day in women) or any other drug abuse 6 Use of any medications that may affect the muscle function or mass such as corticosteroids, anabolic steroids, protein supplements, performance enhancing medications etc.
7 Pregnancy and lactation, any physical deformity or loss of extremity.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in muscle mass and function in sarcopenic individuals	At the end of 6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in metabolic abnormalities such as insulin resistance, dyslipidemia and dysglycemia	At the end of 6 months

Trial Locations

Locations (1): All India Institute of Medical Sciences. new Delhi
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences. new Delhi
🇮🇳South, DELHI, India
Dr Naval K Vikram
Principal investigator
119810007331
navalvikram@gmail.com