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

• ClinicalTrials.gov Identifier: NCT03372876
• Recruitment Status: Completed
• First Posted: December 14, 2017
• Last Update Posted: December 15, 2017
• Sponsor: Federal University of Uberlandia
• Information provided by (Responsible Party): Erick Prado de Oliveira, Federal University of Uberlandia

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
Sarcopenia	Dietary Supplement: Protein and carbohydrate supplementation	Not Applicable

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 (Clinical Trial)
• 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: October 4, 2017
• Actual Study Completion Date: October 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 Name: 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 Name: Resistance exercise

Outcome Measures

Primary Outcome Measures :

1. 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) ]

Secondary Outcome Measures :

1. 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) ]
2. 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) ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Brazil

Erick P. de Oliveira

Uberlândia, Minas Gerais, Brazil, 38.405-320

Sponsors and Collaborators

Federal University of Uberlandia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Erick Prado de Oliveira, PhD, Federal University of Uberlandia
• ClinicalTrials.gov Identifier: NCT03372876
• Other Study ID Numbers: 2.023.127
• First Posted: December 14, 2017
• Last Update Posted: December 15, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• 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; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical