- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862937
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
July 20, 2020 updated by: Cláudia Dornelles Schneider, Federal University of Health Science of Porto Alegre
The increase in life expectancy of the world population is associated with a higher incidence of diseases, leading to functional incapacity and dependence in old age.
Aging is usually accompanied by progressive loss of muscle mass, muscular strength and functional capacity, possibly exacerbated by inactivity and low protein and energy consumption of elderly individuals.
However, the response to strength training, as well as the daily recommendation of protein and other factors related to sarcopenia in this population seem not to be well understood.
Objective: To evaluate the effect of protein intake and resistance training on body composition, muscle strength and functional capacity in the elderly.
METHODS: A randomized placebo-controlled clinical trial will be conducted with 38 elderly people, ≥ 60 years old, sedentary, and body mass index between 22 and 30 kg / m2.
All those who agree to participate will be randomized into two groups (intervention or placebo) and will undergo an initial assessment consisting of food consumption analysis through the application of the three-day food record, assessment of muscle thickness of the thigh and arm by muscle ultrasonography, evaluation of body composition by dual energy X-ray absorptiometry (DEXA), dynamic maximal strength (1RM) test of knee extension and elbow flexion, peak torque test of knee extension, functional capacity tests and quality of life questionnaire (SF-36).
The elderly will participate in resistance training for 12 weeks, two session per week.
The intervention group will be supplemented with whey protein isolate (2x / day - 20g for breakfast and 20g for dinner) and the placebo group will receive maltodextrin (2x / day - 20g for breakfast and 20g for dinner).
All outcomes will be assessed before and after the 12-week resistance training period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
- Federal University of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be 60 or older, and in the case of women, they must be postmenopausal (interruption of menstruation for more than one year).
- Have not participated in any systematic exercise program for at least six months prior to the start of this project.
- To have a body mass index (BMI) between 22 and 30 kg / m2.
- Are not cardiopathic, diabetic or have any other metabolic disease.
- Do not present joint problems or any other injury that prevents the proper execution of the exercises of the training routine.
- Non-smoker or have quit smoking for at least five years ago.
- Release of the doctor (medical certificate) to perform the physical exercises.
Exclusion Criteria:
- Do not participate in at least 20 training sessions or miss more than three consecutive training sessions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
The experimental group will perform 12 weeks of strength training twice a week associated with whey protein supplementation.
|
Whey protein (2x / day - 20g for breakfast and 20g for dinner).
|
Placebo Comparator: Placebo
The placebo group will perform 12 weeks of strength training twice a week associated with maltodextrin supplementation.
|
Maltodextrin (2x / day - 20g for breakfast and 20g for dinner).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Densitometry by dual energy X-ray absorptiometry (DEXA) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
|
Measure body composition, such as total fat mass (kg), total fat-free mass (kg), and fat-free mass in the thigh (kg) will be assessed using Dual Energy X-Ray Absorption Densitometry (HXD) (Hologic Discovery W, USA).
|
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
|
Ultrasonography change from baseline.
Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
|
The evaluation of muscle thickness of the quadriceps femoris muscles, as well as the brachial and brachial biceps will be done by means of an image obtained using the Ulio XG ultrasound device (Toshiba, Japan).
|
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
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Muscular strength (peak of torque) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
|
The torque production rate will be calculated from the torque-time curves obtained during a maximal voluntary isometric contraction of knee extension performed on an isokinetic dynamometer (Cybex, Ronkonkoma, USA).
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This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
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Muscular strength (1-RM) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
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The 1-RM tests (1 maximum repetition test) of knee extension and elbow flexion will be performed in an extensor chair and Scott bench, respectively (Mark Können Gym, China), bilaterally.
|
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
|
Functional capacity (sit and stand up test) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
|
The number of sit and stand movements in the chair will be evaluated in 30 seconds.
|
This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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Functional capacity (timed up and go test) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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The task will be to walk a three-meter course, get around a cone, go back and sit in the chair.
The result will be expressed in seconds.
|
This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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Functional capacity (stair climbing test) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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Task to climb a flight of stairs at a comfortable speed and without the aid of the handrail and the time will be measured in seconds.
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This measure will be performed before and after the intervention (12-week resistance training and supplementation).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Protein intake (dietary record) baseline.
Time Frame: To evaluate the food consumption will be used the dietary record of three days.
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To evaluate the food consumption will be used the dietary record of three days.
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Protein intake (24-hour food recall).
Time Frame: To verify possible changes in dietary intake over the 12 weeks of intervention, a 24-hour food recall will be applied on the fourth and eighth week and immediately after the last training session.
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To verify possible changes in dietary intake over the 12 weeks of intervention, a 24-hour food recall will be applied on the fourth and eighth week and immediately after the last training session.
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Diet Quality Index.
Time Frame: To evaluate the quality of the diet will be used the Healthy Eating Index (HEI) that assigns scores to the diet according to the adequacy of the food and nutrients intake, based on the 24 hour reminders previously applied.
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To evaluate the quality of the diet will be used the Healthy Eating Index (HEI) that assigns scores to the diet according to the adequacy of the food and nutrients intake, based on the 24 hour reminders previously applied.
|
Quality of life (SF-36) change from baseline.
Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation). The SF-36 (Medical Outcomes Study 36) questionnaire will be used to evaluate the quality of life of the elderly.
|
This measure will be performed before and after the intervention (12-week resistance training and supplementation). The SF-36 (Medical Outcomes Study 36) questionnaire will be used to evaluate the quality of life of the elderly.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2019
Primary Completion (Actual)
December 20, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
March 3, 2019
First Submitted That Met QC Criteria
March 3, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Actual)
July 21, 2020
Last Update Submitted That Met QC Criteria
July 20, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUHSPortoAlegre2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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