Clinical trial NCT03792646: Protein Supplementation: Body Composition, Muscle Strength and Postural Balance
Official title: Effect of Protein Supplementation on Body Composition, Muscle Strength and Postural Balance in Elderly Type II Diabetes Subjects Undergoing Resistance Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Protein Supplementation
Body Composition
Inflammation Biomarkers
Resistance Training
Keywords: Supplementary Feeding
Protein
Muscle strenght
Exercise
Aged
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 40
Sex: MALE
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective clinical trial, double-blind, placebo-controlled intervention
Primary purpose: TREATMENT

Brief summary: Nutritional interventions witch stimulate the rate of muscle protein synthesis are relevant for the development of therapeutic strategies aimed at attenuating the loss of mass and muscle strength related to aging (sarcopenia). To aim of the study is to investigate the effect of protein supplementation on body composition, muscle activity, muscle strength and plasma concentration of inflammatory biomarkers of elderly with type II diabetic, submitted to 12 weeks of resistance training. This is an interventional, controlled, randomized, double-blind study. The population of the present study will be composed of 40 men with type 2 diabetes aged between 70 and 74 years, whose body mass index (BMI) should be between 22 and 32 kg / m2. It will be composed of patients from the Diabetes Outpatient Clinic of the Endocrinology Department at the Medical School of the University of São Paulo. Elderly subjects will be randomized into two groups (n = 20) who will undergo resistance training for 12 weeks, twice a week, and receive protein or placebo supplementation. Exercises will be performed for the large muscle groups: pectoral press, paddling, leg-press, extensor chair, gastrocnemius plantar flexions and abdominal crunches. Protein supplementation will be performed immediately after strength training by ingestion of 20 g of whey protein diluted in water. Also, immediately after training the placebo group will receive 20 g of maltodextrin diluted in water. All participants will be instructed to ingest 1.0 to 1.2 g of protein / kg of body weight per day. 24-hour food recall and food frequency questionnaires will be performed throughout the study. The following evaluations (before and after 12 weeks training) will be applied: Anthropometric: body mass, height, BMI and hip waist ratio. Functional evaluation through isokinetic dynamometry of knee extensors and flexors and a maximal repetition (1RM). Evaluation of body composition through Bioimpedance balance. Evaluation of food intake will be obtained by means of a 24-hour recall and food frequency questionnaire. All the evaluations will performed after 6 months. The training sessions will have a frequency of twice a week for 12 weeks. Eight exercises will be performed for the main muscle groups. In each exercise, 3 sets will be performed between 8 and 12 repetitions. The intensity should be between 7 - 8 and will be monitored according to Subjective Effort Perception using a scale of 0 to 10.

Detailed description: Eligibility Criteria:

Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin or combination of both) for three months or more.

Glycated hemoglobin between 6 and 8.5% Renal function assessed by MDRD above 60 ml / h AST and ALT up to 2.5 times the upper limit of the No involvement of the musculoskeletal system with pain and any type of incapacitating disease or previous surgeries.

No chronic non-communicable disease not treated properly and decompensated Renal function assessed by MDRD equal to or above 60 ml / h

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin or combination of both) for three months or more.
* Glycated hemoglobin between 6 and 8.5%
* Renal function assessed by MDRD above 60 ml / h
* AST and ALT up to 2.5 times the upper limit of the
* No involvement of the musculoskeletal system with pain and any type of incapacitating disease or previous surgeries.
* No chronic non-communicable disease not treated properly and decompensated
* Renal function assessed by MDRD equal to or above 60 ml / h

Exclusion Criteria:

• Impossibility to conduct evaluation and training efficiently

Primary outcomes:
measure: Muscular strength (hand grip) change from baseline
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
measure: Muscular strength (peak of torque) change from baseline
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
measure: Muscular strength (total work) change from baseline
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
measure: Postural Balance (weight transfer) change from baseline
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
measure: Postural Balance (sway velocity) change from baseline
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Secondary outcomes:
measure: Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
measure: Portable Bioelectrical Impedance change from baseline
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
measure: Inflammatory biomarkers - plasma concentration change from baseline (Tumor necrosis factor-alpha)
timeFrame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Julia Maria DÀndrea Greve
Study officials:
affiliation: University of Sao Paulo
name: Julia C Greve, Professor
role: PRINCIPAL_INVESTIGATOR
References: