ElderlyNCT03862937
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
A study testing Exercise training + whey protein in people with Elderly and Sarcopenia, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Sarcopenia
- What is being tested?
- Exercise training + whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2019to 20 Dec 2019
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Do not participate in at least 20 training sessions or miss more than three consecutive training sessions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
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.
- Conditions
- Elderly, Sarcopenia
- Being tested
- Exercise training + whey protein, Exercise training + placebo (maltodextrin)
- Keywords
- Protein Supplementation, Body Composition, Resistance Training, Functional Capacity, Muscle Strength
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training + whey proteinDietary supplement
Whey protein (2x / day - 20g for breakfast and 20g for dinner).
Exercise training + placebo (maltodextrin)Other
Maltodextrin (2x / day - 20g for breakfast and 20g for dinner).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will perform 12 weeks of strength training twice a week associated with whey protein supplementation. Receives: Dietary Supplement: Exercise training + whey protein |
| Placebo | Placebo comparator | The placebo group will perform 12 weeks of strength training twice a week associated with maltodextrin supplementation. Receives: Other: Exercise training + placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
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).
Measured: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
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).
Measured: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation).
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.
Measured: 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.
The number of sit and stand movements in the chair will be evaluated in 30 seconds.
Measured: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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.
Measured: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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.
Measured: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
Secondary outcomes (4)
Protein intake (dietary record) baseline.
Measured: To evaluate the food consumption will be used the dietary record of three days.
Protein intake (24-hour food recall).
Measured: 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.
Diet Quality Index.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start3 Mar 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudia Dornelles Schneider, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862937
- Sponsor's protocol ID
- FUHSPortoAlegre2019
- Status last verified
- Jul 2020
- First submitted
- 3 Mar 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
- ClinicalTrials.gov ID
- NCT03862937
- Acronym / sponsor ID
- FUHSPortoAlegre2019
- Conditions
- Elderly, Sarcopenia
- Keywords
- Protein Supplementation, Body Composition, Resistance Training, Functional Capacity, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 5 Mar 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Exercise training + whey proteinThe experimental group will perform 12 weeks of strength training twice a week associated with whey protein supplementation. |
| Placebo | Placebo comparator | Other: Exercise training + placebo (maltodextrin)The placebo group will perform 12 weeks of strength training twice a week associated with maltodextrin supplementation. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Do not participate in at least 20 training sessions or miss more than three consecutive training sessions.
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 |
|---|---|---|
| Exercise training + whey proteinWhey protein (2x / day - 20g for breakfast and 20g for dinner). | Dietary supplement | Experimental |
| Exercise training + placebo (maltodextrin)Maltodextrin (2x / day - 20g for breakfast and 20g for dinner). | Other | Placebo |
Primary outcome
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).
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).
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).
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).
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.
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.
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).
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.
Time frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation).
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.
4 secondary outcomes
Protein intake (dietary record) baseline.
Time frame: To evaluate the food consumption will be used the dietary record of three days.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training + whey protein in people with Elderly and Sarcopenia, run by Federal University of Health Science of Porto Alegre 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: finished, as of the sponsor's last update on 21 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.