NCT03372876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

December 10, 2017

Last Update Submit

December 13, 2017

Conditions

Outcome Measures

Primary Outcomes (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 Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

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.

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.

Dietary Supplement: Protein and carbohydrate supplementation

Interventions

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.

Also known as: Resistance exercise
Carbohydrate-protein (CP) (protein intake far to exercise)Protein-carbohydrate (PC) (protein intake after exercise)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erick P. de Oliveira

Uberlândia, Minas Gerais, 38.405-320, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sarcopenia

Interventions

ProteinsResistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 10, 2017

First Posted

December 14, 2017

Study Start

May 8, 2017

Primary Completion

October 4, 2017

Study Completion

October 11, 2017

Last Updated

December 15, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations