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Protein Supplementation: Body Composition, Muscle Strength and Postural Balance

Primary Purpose

Diabetes Mellitus, Type 2, Protein Supplementation, Body Composition

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Whey protein
Exercise training
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Supplementary Feeding, Protein, Muscle strenght, Exercise, Aged

Eligibility Criteria

65 Years - 79 Years (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Julia Maria DÀndrea GreveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

The experimental group will inject 20 grams of whey protein diluted in water after the exercise training.

The placebo group will inject 20 grams of maltodextrin diluted in water after the exercise training.

Outcomes

Primary Outcome Measures

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.
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 (%).
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).
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 12, 2018
Last Updated
January 2, 2019
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03792646
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Protein Supplementation, Body Composition, Inflammation Biomarkers, Resistance Training
Keywords
Supplementary Feeding, Protein, Muscle strenght, Exercise, Aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective clinical trial, double-blind, placebo-controlled intervention
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will inject 20 grams of whey protein diluted in water after the exercise training.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will inject 20 grams of maltodextrin diluted in water after the exercise training.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
Exercise training + 20g whey protein
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Strength exercise
Primary Outcome Measure Information:
Title
Muscular strength (hand grip) change from baseline
Description
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.
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Title
Muscular strength (peak of torque) change from baseline
Description
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 (%).
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Title
Muscular strength (total work) change from baseline
Description
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).
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Title
Postural Balance (weight transfer) change from baseline
Description
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.
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Title
Postural Balance (sway velocity) change from baseline
Description
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.
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Secondary Outcome Measure Information:
Title
Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)
Description
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.
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
Title
Portable Bioelectrical Impedance change from baseline
Description
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.
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
Title
Inflammatory biomarkers - plasma concentration change from baseline (Tumor necrosis factor-alpha)
Description
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.
Time Frame
This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Greve, Professor
Phone
2661-6908
Email
jgreve@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Guilherme Brech
Phone
11998117869
Email
guibrech@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia C Greve, Professor
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julia Maria DÀndrea Greve
City
São Paulo
ZIP/Postal Code
04503-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme C Brech, PhD
Phone
2661-6908
Email
guibrech@gmail.com
First Name & Middle Initial & Last Name & Degree
Guilherme C Brech, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Protein Supplementation: Body Composition, Muscle Strength and Postural Balance

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