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Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women

Sponsor
Federal University of Uberlandia (Other)
Overall Status
Completed
CT.gov ID
NCT03372876
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
5.1
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Protein and carbohydrate supplementation
 N/A

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

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 8, 2017
Actual Primary Completion Date :
Oct 4, 2017
Actual Study Completion Date :
Oct 11, 2017

Arms and Interventions

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.

Dietary Supplement: Protein and carbohydrate supplementation
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:
  • Resistance exercise

    		•
    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.

    Dietary Supplement: Protein and carbohydrate supplementation
    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:
  • Resistance exercise

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the lean mass of postmenopausal women practicing resistance exercise [Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)]

    Secondary Outcome Measures

    1. Changes on strength of postmenopausal women practicing resistance exercise [Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)]

    2. Changes on functional capacity of postmenopausal women practicing resistance exercise [Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erick P. de Oliveira Uberlândia Minas Gerais Brazil 38.405-320

    Sponsors and Collaborators

    • Federal University of Uberlandia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erick Prado de Oliveira, PhD, Federal University of Uberlandia
    ClinicalTrials.gov Identifier:
    NCT03372876
    Other Study ID Numbers:
    • 2.023.127
    First Posted:
    Dec 14, 2017
    Last Update Posted:
    Dec 15, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sarcopenia

    Study Results

    No Results Posted as of Dec 15, 2017