Diabetes Mellitus, Type 2NCT03792646
Protein Supplementation: Body Composition, Muscle Strength and Postural Balance
A study testing Whey protein and Exercise training in people with Diabetes Mellitus, Type 2 and Protein Supplementation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 65 to 79 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Protein Supplementation, Body Composition
- What is being tested?
- Whey protein and Exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Impossibility to conduct evaluation and training efficiently
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Julia Maria DÀndrea Greve
São Paulo, 04503-010
Guilherme C Brech, PhD, 2661-6908, guibrech@gmail.com
Guilherme C Brech, PhD
About this study
Official title: Effect of Protein Supplementation on Body Composition, Muscle Strength and Postural Balance in Elderly Type II Diabetes Subjects Undergoing Resistance Training
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 2, Protein Supplementation, Body Composition, Inflammation Biomarkers, Resistance Training
- Being tested
- Whey protein, Exercise training
- Keywords
- Supplementary Feeding, Protein, Muscle strenght, Exercise, Aged
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Exercise training + 20g whey protein
Exercise trainingOther
Strength exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will inject 20 grams of whey protein diluted in water after the exercise training. Receives: 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. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (%).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
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.
Measured: 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)
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.
Measured: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 May 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective clinical trial, double-blind, placebo-controlled intervention
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia C Greve, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792646
- Sponsor's protocol ID
- Diabéticos
- Status last verified
- Mar 2018
- First submitted
- 12 Nov 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37239618
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Supplementation on Body Composition, Muscle Strength and Postural Balance in Elderly Type II Diabetes Subjects Undergoing Resistance Training
- ClinicalTrials.gov ID
- NCT03792646
- Acronym / sponsor ID
- Diabéticos
- Conditions
- Diabetes Mellitus, Type 2, Protein Supplementation, Body Composition, Inflammation Biomarkers, Resistance Training
- Keywords
- Supplementary Feeding, Protein, Muscle strenght, Exercise, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized prospective clinical trial, double-blind, placebo-controlled intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Whey protein, Other: Exercise trainingThe experimental group will inject 20 grams of whey protein diluted in water after the exercise training. |
| Placebo | Placebo comparator | Other: Exercise trainingThe placebo group will inject 20 grams of maltodextrin diluted in water after the exercise training. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Impossibility to conduct evaluation and training efficiently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey proteinExercise training + 20g whey protein | Dietary supplement | Experimental |
| Exercise trainingStrength exercise | Other | Experimental, Placebo |
Primary outcome
Muscular strength (hand grip) change from baseline
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
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
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
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
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
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
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
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
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
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.
3 secondary outcomes
Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
Portable Bioelectrical Impedance change from baseline
Time frame: 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)
Time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 37239618Soares 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia C Greve, Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and Exercise training in people with Diabetes Mellitus, Type 2 and Protein Supplementation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Greve, Professor (2661-6908, jgreve@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength (hand grip) change from baseline (time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.