The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. This study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. The results obtained could represent new therapeutic protocols in the treatment of obesity.
Several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of SO. The supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of ATP - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Comparison of the efficacy
Comparison of the efficacy
Comparison of the efficacy
Comparison of the efficacy
Amelia Brunani
Verbania, VB, Italy
Change of Body weight
weight in kilograms
Time frame: basal and at 4 weeks
Change of Height
height in meters
Time frame: basal and at 4 weeks
Change of BMI
weight and height will be combined to report BMI in kg/m\^2
Time frame: basal and at 4 weeks
Change of Waist
waist circumference in centimeters
Time frame: basal and at 4 weeks
Change of FM
Fat Mass (FM) in % of body weight in kilograms
Time frame: basal and at 4 weeks
Change of FFM
Free Fat Mass (FFM) in % of body weight in kilograms
Time frame: basal and at 4 weeks
Change of MM
Muscle Mass (MM) in % of body weight in kilograms
Time frame: basal and at 4 weeks
Change of Muscle strenght
muscle streght at the hand (right and left) in kg
Time frame: basal and at 4 weeks
Change of Walking
6 minute walk test (6MWT), meters walking in 6 minutes
Time frame: basal and at 4 weeks
Change of TUG
time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down
Time frame: basal and at 4 weeks
Change of Metabolic profile
glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl
Time frame: basal and at 4 weeks
Change of Insulin secretion
insulin pasma levels in mU/l
Time frame: basal and at 4 weeks
Change of Homa index
glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l
Time frame: basal and at 4 weeks
Change of Muscle function
irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml
Time frame: basal and at 4 weeks
Change of Muscle wasting
C-terminal agrin fragment (CAF) in pg/ml
Time frame: basal and at 4 weeks
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