Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
Primary Purpose
Elderly, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training + whey protein
Exercise training + placebo (maltodextrin)
Sponsored by
About this trial
This is an interventional treatment trial for Elderly focused on measuring Protein Supplementation, Body Composition, Resistance Training, Functional Capacity, Muscle Strength
Eligibility Criteria
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.
Sites / Locations
- Federal University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo
Arm Description
The experimental group will perform 12 weeks of strength training twice a week associated with whey protein supplementation.
The placebo group will perform 12 weeks of strength training twice a week associated with maltodextrin supplementation.
Outcomes
Primary Outcome Measures
Densitometry by dual energy X-ray absorptiometry (DEXA) change from baseline.
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).
Ultrasonography change from baseline.
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).
Muscular strength (peak of torque) change from baseline.
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).
Muscular strength (1-RM) change from baseline.
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.
Functional capacity (sit and stand up test) change from baseline.
The number of sit and stand movements in the chair will be evaluated in 30 seconds.
Functional capacity (timed up and go test) change from baseline.
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.
Functional capacity (stair climbing test) change from baseline.
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.
Secondary Outcome Measures
Protein intake (dietary record) baseline.
Protein intake (24-hour food recall).
Diet Quality Index.
Quality of life (SF-36) change from baseline.
Full Information
NCT ID
NCT03862937
First Posted
March 3, 2019
Last Updated
July 20, 2020
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03862937
Brief Title
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
Official Title
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Sarcopenia
Keywords
Protein Supplementation, Body Composition, Resistance Training, Functional Capacity, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will perform 12 weeks of strength training twice a week associated with whey protein supplementation.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will perform 12 weeks of strength training twice a week associated with maltodextrin supplementation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Exercise training + whey protein
Intervention Description
Whey protein (2x / day - 20g for breakfast and 20g for dinner).
Intervention Type
Other
Intervention Name(s)
Exercise training + placebo (maltodextrin)
Intervention Description
Maltodextrin (2x / day - 20g for breakfast and 20g for dinner).
Primary Outcome Measure Information:
Title
Densitometry by dual energy X-ray absorptiometry (DEXA) change from baseline.
Description
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).
Time Frame
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
Title
Ultrasonography change from baseline.
Description
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).
Time Frame
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
Title
Muscular strength (peak of torque) change from baseline.
Description
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).
Time Frame
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
Title
Muscular strength (1-RM) change from baseline.
Description
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.
Time Frame
This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
Title
Functional capacity (sit and stand up test) change from baseline.
Description
The number of sit and stand movements in the chair will be evaluated in 30 seconds.
Time Frame
This measure will be performed before and after the intervention (12-week resistance training and supplementation).
Title
Functional capacity (timed up and go test) change from baseline.
Description
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.
Time Frame
This measure will be performed before and after the intervention (12-week resistance training and supplementation).
Title
Functional capacity (stair climbing test) change from baseline.
Description
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.
Time Frame
This measure will be performed before and after the intervention (12-week resistance training and supplementation).
Secondary Outcome Measure Information:
Title
Protein intake (dietary record) baseline.
Time Frame
To evaluate the food consumption will be used the dietary record of three days.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Health Sciences
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
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