- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372876
Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women
December 13, 2017 updated by: Erick Prado de Oliveira, Federal University of Uberlandia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
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
-
-
Minas Gerais
-
Uberlândia, Minas Gerais, Brazil, 38.405-320
- Erick P. de Oliveira
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protein-carbohydrate (PC) (protein intake after exercise)
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.
|
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.
Other Names:
|
|
Placebo Comparator: Carbohydrate-protein (CP) (protein intake far to exercise)
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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)
|
Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
May 8, 2017
Primary Completion (Actual)
October 4, 2017
Study Completion (Actual)
October 11, 2017
Study Registration Dates
First Submitted
December 10, 2017
First Submitted That Met QC Criteria
December 10, 2017
First Posted (Actual)
December 14, 2017
Study Record Updates
Last Update Posted (Actual)
December 15, 2017
Last Update Submitted That Met QC Criteria
December 13, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.023.127
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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