Clinical trial NCT05457088: High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus
Official title: The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: older adults
dietary protein
nutrition intervention
sarcopenia
performance
oxidative stress
inflammation
biochemical profile
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Harokopio University
First posted: 2022-07-13
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1st group will receive a dietary plan having dietary protein of 1.5gr/kg/day.2nd group will receive a dietary plan having dietary protein of 0.8gr/kg/day.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: skeletal muscle mass index
timeFrame: Week 0, week 12
measure: calf circumference
timeFrame: Week 0, week 6, week 12
measure: handgrip strength
timeFrame: Week 0, week 6, week 12
measure: Sit to stand test
timeFrame: Week 0, week 6, week 12
measure: Timed up and go test
timeFrame: Week 0, week 6, week 12
measure: 10 meters walking test
timeFrame: Week 0, week 6, week 12
measure: blood glucose
timeFrame: Week 0, week 6, week 12
measure: Serum insulin
timeFrame: Week 0, week 6, week 12
measure: Glycosylated hemoglobin (HbA1)
timeFrame: Week 0, week 6, week 12
measure: C reactive protein
timeFrame: Week 0, week 6, week 12
measure: Dietary intake of macro- and micro-nutrients
timeFrame: Week 0, week 3 , week 6, week 9, week 12
Secondary outcomes:
measure: cholesterol level
timeFrame: Week 0, week 6, week 12
measure: triglycerides level
timeFrame: Week 0, week 6, week 12
measure: low-density lipoprotein (LDL)
timeFrame: Week 0, week 6, week 12
measure: high-density lipoprotein (HDL)
timeFrame: Week 0, week 6, week 12
measure: Enzymatic activity of glutathione peroxidase in plasma
timeFrame: Week 0, week 6, week 12
measure: Enzymatic activity of glutathione peroxidase in red blood cell lysate
timeFrame: Week 0, week 6, week 12
measure: Enzymatic activity of superoxide dismutase in plasma
timeFrame: Week 0, week 6, week 12
measure: Enzymatic activity of superoxide dismutase in red blood cell lysate
timeFrame: Week 0, week 6, week 12
measure: Protein carbonyls in plasma
timeFrame: Week 0, week 6, week 12
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
state: Attiki
Study officials:
References:
citation: Argyropoulou D, Geladas ND, Nomikos T, Paschalis V. Exercise and Nutrition Strategies for Combating Sarcopenia and Type 2 Diabetes Mellitus in Older Adults. J Funct Morphol Kinesiol. 2022 Jun 8;7(2):48. doi: 10.3390/jfmk7020048.