High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Type2 Diabetes Mellitus

Treatments: Other: 1.5 protein; Other: 0.8 protein

Study type: Interventional

Funder types: Other

Identifiers

NCT05457088

1288/03-07-2021

Details and patient eligibility

About

This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.

Enrollment: 25 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must have been diagnosed with type 2 diabetes mellitus during the last 5 years
• must have BMI 18.5-24.9

Exclusion criteria

• receive dietary supplements
• extreme dietary habits
• chronic inflammation disease
• cancer
• autoimmune disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

intervention group

Experimental group

Description:

Dietary intervention with protein intake 1.5 gr/kg/day

Treatment:

Other: 1.5 protein

control group

Experimental group

Description:

Dietary intervention with protein intake 0.8 gr/kg/day

Treatment:

Other: 0.8 protein