SarcopeniaNCT03372876
Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women
A study testing Protein and carbohydrate supplementation in people with Sarcopenia, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
This study evaluated the effect of protein intake immediately after resistance exercise on lean mass, strength, and functional capacity gains in postmenopausal women. Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein and carbohydrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2017to 11 Oct 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
- Healthy;
- Who agree to participate and sign the consent term.
Who cannot join
- The one who does not provide the necessary information for the development of the study;
- Present orthopedic limitations;
- Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protein Intake Immediately After Resistance Exercise Does Not Promote Additional Increase on Lean Mass, Strength and Functional Capacity in Postmenopausal Women: a Randomized Clinical Trial
This study evaluated the effect of protein intake immediately after resistance exercise on lean mass, strength, and functional capacity gains in postmenopausal women. Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning.
Read the detailed description
Both groups performed the same training protocol, differing only the time of protein or carbohydrate supplementation. The dietary assessment was made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. One maximum repetition (1-RM), handgrip strength and 1-mile walk were performed.
- Conditions
- Sarcopenia
- Being tested
- Protein and carbohydrate supplementation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein and carbohydrate supplementationDietary supplement
Also called Resistance exercise
Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning, 3 times a week, at 70% of 1-maximum repetition (1-RM) during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Protein-carbohydrate (PC) (protein intake after exercise) | Experimental | ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon. The resistance exercise was performed equally by both groups. Receives: Dietary Supplement: Protein and carbohydrate supplementation |
| Carbohydrate-protein (CP) (protein intake far to exercise) | Placebo comparator | ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. The resistance exercise was performed equally by both groups. Receives: Dietary Supplement: Protein and carbohydrate supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the lean mass of postmenopausal women practicing resistance exercise
Measured: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
Secondary outcomes (2)
Changes on strength of postmenopausal women practicing resistance exercise
Measured: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
Changes on functional capacity of postmenopausal women practicing resistance exercise
Measured: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start8 May 2017
- Primary completion4 Oct 2017
- Study completion11 Oct 2017
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 SarcopeniaStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick Prado de Oliveira, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372876
- Sponsor's protocol ID
- 2.023.127
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Branco FMS, Carneiro MAS, Rossato LT, Nahas PC, Teixeira KRC, de Oliveira GN Jr, Orsatti FL, de Oliveira EP. Protein timing has no effect on lean mass, strength and functional capacity gains induced by resistance exercise in postmenopausal women: A randomized clinical trial. Clin Nutr. 2020 Jan;39(1):57-66. doi: 10.1016/j.clnu.2019.01.008. Epub 2019 Jan 17.
PubMed 30691866
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Intake Immediately After Resistance Exercise Does Not Promote Additional Increase on Lean Mass, Strength and Functional Capacity in Postmenopausal Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03372876
- Acronym / sponsor ID
- 2.023.127
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 14 Dec 2017 (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.
This study evaluated the effect of protein intake immediately after resistance exercise on lean mass, strength, and functional capacity gains in postmenopausal women. Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning.
Detailed description
Both groups performed the same training protocol, differing only the time of protein or carbohydrate supplementation. The dietary assessment was made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. One maximum repetition (1-RM), handgrip strength and 1-mile walk were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein-carbohydrate (PC) (protein intake after exercise) | Experimental | Dietary Supplement: Protein and carbohydrate supplementationingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon. The resistance exercise was performed equally by both groups. |
| Carbohydrate-protein (CP) (protein intake far to exercise) | Placebo comparator | Dietary Supplement: Protein and carbohydrate supplementationingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. The resistance exercise was performed equally by both groups. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
- Healthy;
- Who agree to participate and sign the consent term.
Key exclusion criteria (3 listed)
- The one who does not provide the necessary information for the development of the study;
- Present orthopedic limitations;
- Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
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 |
|---|---|---|
| Protein and carbohydrate supplementationAlso: Resistance exerciseParticipants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning, 3 times a week, at 70% of 1-maximum repetition (1-RM) during 8 weeks. | Dietary supplement | Carbohydrate-protein (CP) (protein intake far to exercise), Protein-carbohydrate (PC) (protein intake after exercise) |
Primary outcome
Changes in the lean mass of postmenopausal women practicing resistance exercise
Time frame: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
2 secondary outcomes
Changes on strength of postmenopausal women practicing resistance exercise
Time frame: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
Changes on functional capacity of postmenopausal women practicing resistance exercise
Time frame: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
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 Dec 2017.
- Derived from this study: PubMed 30691866de Branco FMS, Carneiro MAS, Rossato LT, Nahas PC, Teixeira KRC, de Oliveira GN Jr, Orsatti FL, de Oliveira EP. Protein timing has no effect on lean mass, strength and functional capacity gains induced by resistance exercise in postmenopausal women: A randomized clinical trial. Clin Nutr. 2020 Jan;39(1):57-66. doi: 10.1016/j.clnu.2019.01.008. Epub 2019 Jan 17.
- 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 Protein and carbohydrate supplementation in people with Sarcopenia, run by Federal University of Uberlandia 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 3 inclusion and 3 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 Dec 2017. 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?
Changes in the lean mass of postmenopausal women practicing resistance exercise (time frame: Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)). 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 NCT03372876, 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 15 Dec 2017.