ClinicalTrials.Veeva

Menu

Effects of Whey Protein Supplementation Collagen Associated to Resistance Training in Older Woman

U

Universidade Estadual de Londrina

Status

Completed

Conditions

Collagen Degeneration
Sarcopenia

Treatments

Dietary Supplement: Whey protein plus collagen
Dietary Supplement: Whey protein plus maltodextrin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04621383
GPMN2019/02

Details and patient eligibility

About

The main purpose of the present study was to investigate the effects of whey protein with collagen hydrolyzed following resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women

Full description

his two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 17 weeks. At the beginning of the experiment, two weeks and at the end three weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16), magnetic ressonance imaging (weeks 2 and 17) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.

Recruitment was carried out through newspapers, radio advertising, and home delivery of leaflets in the central area and residential neighborhoods. All participants completed health history and physical activity questionnaires and were included in the study if they met the following inclusion criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction that would prevent them from performing the prescribed exercise or exercise testing associated with the study, not receiving hormonal replacement therapy, and completed a previous 8-week RT programParticipants underwent a diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed by a cardiologist and were released with no restrictions for participation in this investigation.

A blinded researcher was responsible for generating random numbers for participant allocation. Both groups were submitted to the same RT program and all participants completed the experiment. Written informed consent was obtained from all participants after a detailed description of investigation procedures was provided. This investigation was conducted according to the Declaration of Helsinki and was approved by the local University Ethics Committee The Shapiro Wilk test will be used to test data distribution. Data will be presented as means, standard deviation, and z-score. The student's independent t-test and chi-square test were will be used to compare groups regarding the general characteristics and clinical/medical history (categorical variables). Two-way analysis of variance (ANOVA) for repeated measures will be used to assess between group comparisons. The effect size (ES) will be calculated to verify the magnitude of the differences by Cohen's d, where an ES of 0.20-0.49 will be considered as small, 0.50-0.79 as moderate, and ≥ 0.80 as large(41). The Z-score of the percentage changes (from pre- to post-training) of the raw data for each parameter will be calculated, as well as a total Z-score, derived from all the components. To verify the differences between groups in total Z-scores, an independent T test will be also applied. For all statistical analyses, significance was accepted at P < 0.05. The data will be analyzed using SPSS software version 20.0 (SPSS, Inc., Chicago, IL, USA).

Enrollment

67 patients

Sex

Female

Ages

60 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

60 years old or more, physically independent, free from cardiac or orthopedic dysfunction that would prevent them from performing the prescribed exercise or exercise testing associated with the study, not receiving hormonal replacement therapy, and completed a previous 8-week RT program. In this study, only women with SO were included. SO was defined as a body fat mass ≥ 35% combined with appendicular lean soft tissue (ALST) less than <15.02 kg, assessed by dual x-ray energy absorptiometry (DXA). Participants underwent a diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed by a cardiologist and were released with no restrictions for participation in this investigation.

Exclusion criteria

All subjects not participating in 85% of the total sessions of training or withdraw

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

67 participants in 2 patient groups, including a placebo group

whey protein plus collagen group
Experimental group
Description:
Participants received a dose of 30 grams of whey protein plus 20 grams of collagen seven days a week splitted in two servings a day, first one in morning, second one in evening. Participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, with 3 sets of 08-12 repetition maximums. The RT program was a whole-body program with eight exercises, including: chest press, seated row, triceps push-down, preacher curl, horizontal leg press, knee extension, leg curl and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise.
Treatment:
Dietary Supplement: Whey protein plus collagen
whey protein plus maltodextrin group
Placebo Comparator group
Description:
Participants received a dose of 30 grams of whey protein plus 20 grams of maltodextrin seven days a week splitted in two servings a day, first one in morning, second one in evening. Participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, with 3 sets of 08-12 repetition maximums. The RT program was a whole-body program with eight exercises, including: chest press, seated row, triceps push-down, preacher curl, horizontal leg press, knee extension, leg curl and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise.
Treatment:
Dietary Supplement: Whey protein plus maltodextrin

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems