Protein Supplementation: Body Composition, Muscle Strength and Postural Balance

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Protein Supplementation on Body Composition, Muscle Strength and Postural Balance in Elderly Type II Diabetes Subjects Undergoing Resistance Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792646
• Other study ID #: Diabéticos
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2018
• Source: University of Sao Paulo General Hospital
• Contact: Julia Greve, Professor
• Phone: 2661-6908
• Email: jgreve[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Inflammation Biomarkers
• Protein Supplementation
• Resistance Training

Intervention

Dietary Supplement:
• Whey protein
Exercise training + 20g whey protein

Other:
• Exercise training
Strength exercise

Locations

Country	Name	City	State
Brazil	Julia Maria DÀndrea Greve	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular strength (hand grip) change from baseline	Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists.	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Primary	Muscular strength (peak of torque) change from baseline	Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used was maximum peak torque corrected for body weight (%).	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Primary	Muscular strength (total work) change from baseline	Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used was total work (J).	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Primary	Postural Balance (weight transfer) change from baseline	The postural balance assessment (posturography) was performed on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, Oregon, USA). The parameter measured was the mean weight transfer. The weight transfer was the time in seconds required to voluntarily shift the COG forwards, beginning in the seated position and ending with full weight-bearing on the feet.	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Primary	Postural Balance (sway velocity) change from baseline	The postural balance assessment (posturography) was performed on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, Oregon, USA). The parameter measured was the center of gravity (COG) sway velocity while rising. The COG sway velocity documented the degree of control over the COG above the support base during the rising phase and for 5 seconds thereafter. Sway was expressed in degrees per second.	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Secondary	Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)	Peripheral blood samples (20 mL) will be collected in tubes containing EDTA anticoagulant at the initial times and 12 weeks of treatment. The total EDTA blood will be centrifuged to obtain the plasma, which will be used to evaluate the concentration of Interleukin 6 (IL-6). IL-6 is an interleukin that acts as a proinflammatory cytokine and an anti-inflammatory miocin. The IL-6 will be measure in microliter (µl)/pictogram (pg). From the whole blood with EDTA will be performed the complete blood count.	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
Secondary	Portable Bioelectrical Impedance change from baseline	Measure body composition, such as % body fat and fat-free mass (FFM). The total body mass and body composition will be measured using a multipolar bio-impedance scale of the brand INBODY® model 230.	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Secondary	Inflammatory biomarkers - plasma concentration change from baseline (Tumor necrosis factor-alpha)	Peripheral blood samples (20 mL) will be collected in tubes containing EDTA anticoagulant at the initial times and 12 weeks of treatment. The total EDTA blood will be centrifuged to obtain the plasma, which will be used to evaluate the concentration of tumor necrosis factor (TNF) -alpha. The TNF-alfa is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The TNF-alfa wiil be measure in microliter (µl)/pictogram (pg). From the whole blood with EDTA will be performed the complete blood count.	This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).