NCT03792646

Protein Supplementation: Body Composition, Muscle Strength and Postural Balance

Status unknown NA Last updated 3 January 2019

What this trial tests

NA trial testing Whey protein in Diabetes Mellitus, Type 2 in 40 participants. Status unknown.

Timeline

1 May 2018

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 May 2018
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Whey protein
• Exercise training

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Protein Supplementation — all drugs for Protein Supplementation →
• Body Composition — all drugs for Body Composition →
• Inflammation Biomarkers — all drugs for Inflammation Biomarkers →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 65 to 79, male only, with Diabetes Mellitus, Type 2 or Protein Supplementation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Soares ALS, Machado-Lima A, Brech GC, Greve JMD, et al · · 2023 · cited 10× · PMID 37239618 · DOI 10.3390/ijerph20105891
2. Can 12-Week Resistance Training Improve Muscle Strength, Dynamic Balance and the Metabolic Profile in Older Adults with Type 2 Diabetes Mellitus?
   de Seixas Soares AL, Brech GC, Machado-Lima A, Dos Santos JR, et al · · 2025 · cited 4× · PMID 40003410 · DOI 10.3390/ijerph22020184