Protein Supplementation: Body Composition, Muscle Strength and Postural Balance

NCT03792646 | Unknown

• 1 other identifier: Diabéticos
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Supplementary Feeding; Protein; Muscle strenght; Exercise; Aged

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)

  This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).

• Portable Bioelectrical Impedance change from baseline

  This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.

• Inflammatory biomarkers - plasma concentration change from baseline (Tumor necrosis factor-alpha)

  This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).

Study Arms (2)

Experimental

EXPERIMENTAL

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

Dietary Supplement: Whey protein; Other: Exercise training

Placebo

PLACEBO COMPARATOR

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

Other: Exercise training

Interventions

Whey protein DIETARY_SUPPLEMENT

Exercise training + 20g whey protein

Experimental

Exercise training OTHER

Strength exercise

Experimental; Placebo

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Impossibility to conduct evaluation and training efficiently

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Julia Maria DÀndrea Greve

São Paulo, 04503-010, Brazil

RECRUITING

Related Publications (1)

• Soares ALS, Machado-Lima A, Brech GC, Greve JMD, Dos Santos JR, Inojossa TR, Rogero MM, Salles JEN, Santarem-Sobrinho JM, Davis CL, Alonso AC. The Influence of Whey Protein on Muscle Strength, Glycemic Control and Functional Tasks in Older Adults with Type 2 Diabetes Mellitus in a Resistance Exercise Program: Randomized and Triple Blind Clinical Trial. Int J Environ Res Public Health. 2023 May 20;20(10):5891. doi: 10.3390/ijerph20105891.

  PMID: 37239618 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Whey Proteins; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julia C Greve, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Greve, Professor

CONTACT

2661-6908; jgreve@usp.br

Guilherme Brech

CONTACT

11998117869; guibrech@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective clinical trial, double-blind, placebo-controlled intervention

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: January 3, 2019
• Study Start: May 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 3, 2019

Record last verified: 2018-03

Locations

BR (1)