NCT04621383

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
Last Updated

March 30, 2025

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 3, 2020

Last Update Submit

March 25, 2025

Conditions

Keywords

Resistance trainingSarcopeniaKnee JointCardiometabolic BiomarkersLean mass

Outcome Measures

Primary Outcomes (3)

  • Change in body composition

    Whole-body dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy) was used to assess lean mass and fat mass and its segments. The total skeletal muscle mass (SMM) was estimated by the predictive equation proposed by Kim et al. (Kim et al., 2004). The results are presented in kg.

    baseline and after 12 weeks

  • Change in Muscular strength

    Maximal dynamic strength was evaluated using the 1RM test assessed on chest press, knee extension, and preacher curl exercises performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load in three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the last resistance lifted in which the subject was able to complete only one single maximal execution

    baseline and after 12 weeks

  • Change in knee cartilage

    Magnetic resonance imaging was used to access the thickness of knee cartilage in multiaxial protocol. the total cartilage was measured by a trained tecnician on images. The results are presented in mm.

    baseline and after 12 weeks

Secondary Outcomes (20)

  • Change in Total cholesterol

    Measurements of serum levels of total cholesterol were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.

  • Change in high-density lipoprotein (HDL-C)

    baseline and after 12 weeks

  • Change in triglycerides

    baseline and after 12 weeks

  • Change in low-density lipoprotein

    baseline and after 12 weeks

  • Change in glucose

    baseline and after 12 weeks

  • +15 more secondary outcomes

Study Arms (2)

whey protein plus collagen group

EXPERIMENTAL

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.

Dietary Supplement: Whey protein plus collagen

whey protein plus maltodextrin group

PLACEBO COMPARATOR

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.

Dietary Supplement: Whey protein plus maltodextrin

Interventions

Whey protein plus collagenDIETARY_SUPPLEMENT

This 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.

whey protein plus collagen group

This 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.

whey protein plus maltodextrin group

Eligibility Criteria

Age60 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo dos Reis Fernandes

Londrina, Paraná, 86015-610, Brazil

Location

Related Publications (3)

  • American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.

    PMID: 19204579BACKGROUND
  • Sardinha LB, Lohman TG, Teixeira PJ, Guedes DP, Going SB. Comparison of air displacement plethysmography with dual-energy X-ray absorptiometry and 3 field methods for estimating body composition in middle-aged men. Am J Clin Nutr. 1998 Oct;68(4):786-93. doi: 10.1093/ajcn/68.4.786.

    PMID: 9771855BACKGROUND
  • Kim J, Heshka S, Gallagher D, Kotler DP, Mayer L, Albu J, Shen W, Freda PU, Heymsfield SB. Intermuscular adipose tissue-free skeletal muscle mass: estimation by dual-energy X-ray absorptiometry in adults. J Appl Physiol (1985). 2004 Aug;97(2):655-60. doi: 10.1152/japplphysiol.00260.2004. Epub 2004 Apr 16.

    PMID: 15090482BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Whey ProteinsCollagenmaltodextrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteins

Study Officials

  • Edilson S Cyrino, PhD.

    Universidade Estadual de Londrina

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

May 27, 2019

Primary Completion

July 5, 2019

Study Completion

December 4, 2019

Last Updated

March 30, 2025

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations