Frail Elderly SyndromeNCT01890382
Protein Intake and Resistance Training in Aging
A study testing Whey protein, whey plus creatine and leucine supplementation in people with Frail Elderly Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Whey protein, whey plus creatine and leucine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2015to 30 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly people
- frailty or pre-frailty, according to Fried et al., (2001) criteria.
Who cannot join
- on exogenous insulin and steroid-based drugs
- chronic obstructive pulmonary disease or respiratory failure
- use of protein and /or amine-based dietary supplements
- on restrictive diets (e.g. calorie or food group restrictions)
- on resistance training
- untreated cardiovascular, metabolic, or other chronic disease
- any musculoskeletal condition precluding resistance training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Protein and Derivatives Supplementation Strategies Combined With Resistance Training in Pre-frail and Frail Elderly
Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. These series of clinical trials aim to investigate the chronic effects of different strategies of protein and derivatives supplementation in association with resistance training on selected health-related parameters in pre-frail and frail elderly.This is a 16-month, double-blind, randomized, placebo-controlled, parallel-group clinical trial involving a series of investigations. Participants will be divided into nine groups, allowing the assessement of the effects of (1) isolated leucine supplementation; (2) protein source (whey vs. soy); (3) combination of whey protein and creatine; and (4) sexual dimorphism to the response of protein intake plus resistance training (men vs. women). All participants will undergo a supervised, resistance training program.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Whey protein, whey plus creatine, leucine supplementation, soy protein, creatine
- Keywords
- resistance exercise, protein, creatine, leucine, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
30 g in total; twice a day (morning and evening)
whey plus creatineDietary supplement
whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)
leucine supplementationDietary supplement
7.5 g/d in total; three times per day
soy proteinDietary supplement
30 g in total; twice a day
creatineDietary supplement
6.0 g in total; twice a day
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | alanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage) Receives: Dietary Supplement: placebo |
| whey protein | Experimental | Not described Receives: Dietary Supplement: Whey protein |
| soy protein | Experimental | Not described Receives: Dietary Supplement: soy protein |
| leucine supplementation | Experimental | Not described Receives: Dietary Supplement: leucine supplementation |
| whey plus creatine | Experimental | Not described Receives: Dietary Supplement: whey plus creatine |
| creatine | Experimental | Not described Receives: Dietary Supplement: creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean mass
assessed by Dual-energy X-ray absorptiometry
Measured: 4 months
muscle function
assessed by a battery of physical tests
Measured: 4 months
Secondary outcomes (3)
bone mass
assessed by Dual-energy X-ray absorptiometry
Measured: 4 months
insulin sensitivity
assessed by homeostasis model assessment (HOMA index)
Measured: 4 months
health related-quality of life
assessed by Short-Form Health Survey (SF-36) (score range: 0 to 100, higher values mean better quality of life)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study start1 Oct 2015
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Bruno Gualano, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890382
- Sponsor's protocol ID
- The Pro Elderly Study
- Status last verified
- Feb 2019
- First submitted
- 26 Jun 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Roschel H, Hayashi AP, Fernandes AL, Jambassi-Filho JC, Hevia-Larrain V, de Capitani M, Santana DA, Goncalves LS, de Sa-Pinto AL, Lima FR, Sapienza MT, Duarte AJS, Pereira RMR, Phillips SM, Gualano B. Supplement-based nutritional strategies to tackle frailty: A multifactorial, double-blind, randomized placebo-controlled trial. Clin Nutr. 2021 Aug;40(8):4849-4858. doi: 10.1016/j.clnu.2021.06.024. Epub 2021 Jul 3.
PubMed 34358827Collins J, Longhurst G, Roschel H, Gualano B. Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty. J Frailty Aging. 2016;5(2):126-34. doi: 10.14283/jfa.2016.85.
PubMed 27224505
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Protein and Derivatives Supplementation Strategies Combined With Resistance Training in Pre-frail and Frail Elderly
- ClinicalTrials.gov ID
- NCT01890382
- Acronym / sponsor ID
- The Pro Elderly Study
- Conditions
- Frail Elderly Syndrome
- Keywords
- resistance exercise, protein, creatine, leucine, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 1 Jul 2013 (estimated)
- 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.
Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. These series of clinical trials aim to investigate the chronic effects of different strategies of protein and derivatives supplementation in association with resistance training on selected health-related parameters in pre-frail and frail elderly.This is a 16-month, double-blind, randomized, placebo-controlled, parallel-group clinical trial involving a series of investigations. Participants will be divided into nine groups, allowing the assessement of the effects of (1) isolated leucine supplementation; (2) protein source (whey vs. soy); (3) combination of whey protein and creatine; and (4) sexual dimorphism to the response of protein intake plus resistance training (men vs. women). All participants will undergo a supervised, resistance training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: placeboalanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage) |
| whey protein | Experimental | Dietary Supplement: Whey protein |
| soy protein | Experimental | Dietary Supplement: soy protein |
| leucine supplementation | Experimental | Dietary Supplement: leucine supplementation |
| whey plus creatine | Experimental | Dietary Supplement: whey plus creatine |
| creatine | Experimental | Dietary Supplement: creatine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- elderly people
- frailty or pre-frailty, according to Fried et al., (2001) criteria.
Key exclusion criteria (7 listed)
- on exogenous insulin and steroid-based drugs
- chronic obstructive pulmonary disease or respiratory failure
- use of protein and /or amine-based dietary supplements
- on restrictive diets (e.g. calorie or food group restrictions)
- on resistance training
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 protein30 g in total; twice a day (morning and evening) | Dietary supplement | whey protein |
| whey plus creatinewhey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively) | Dietary supplement | whey plus creatine |
| leucine supplementation7.5 g/d in total; three times per day | Dietary supplement | leucine supplementation |
| soy protein30 g in total; twice a day | Dietary supplement | soy protein |
| creatine6.0 g in total; twice a day | Dietary supplement | creatine |
| placebo | Dietary supplement | Control |
Primary outcome
lean mass
Time frame: 4 months
assessed by Dual-energy X-ray absorptiometry
muscle function
Time frame: 4 months
assessed by a battery of physical tests
3 secondary outcomes
bone mass
Time frame: 4 months
insulin sensitivity
Time frame: 4 months
health related-quality of life
Time frame: 4 months
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 15 Feb 2019.
- Derived from this study: PubMed 34358827Roschel H, Hayashi AP, Fernandes AL, Jambassi-Filho JC, Hevia-Larrain V, de Capitani M, Santana DA, Goncalves LS, de Sa-Pinto AL, Lima FR, Sapienza MT, Duarte AJS, Pereira RMR, Phillips SM, Gualano B. Supplement-based nutritional strategies to tackle frailty: A multifactorial, double-blind, randomized placebo-controlled trial. Clin Nutr. 2021 Aug;40(8):4849-4858. doi: 10.1016/j.clnu.2021.06.024. Epub 2021 Jul 3.
- Derived from this study: PubMed 27224505Collins J, Longhurst G, Roschel H, Gualano B. Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty. J Frailty Aging. 2016;5(2):126-34. doi: 10.14283/jfa.2016.85.
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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.
Bruno Gualano, 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, whey plus creatine and leucine supplementation in people with Frail Elderly Syndrome, run by University of Sao Paulo 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 2 inclusion and 7 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 15 Feb 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?
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?
lean mass (time frame: 4 months). The study lists 2 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 NCT01890382, which also lists 2 linked publications.
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 15 Feb 2019.