- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621383
Effects of Whey Protein Supplementation Collagen Associated to Resistance Training in Older Woman
Effects of Whey Protein Supplementation With Hydrolyzed Collagen Associated With 12 Weeks of Resistance Training on Body Composition, Blood Biomarkers and Muscle Strength in Elderly Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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PR
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Londrina, PR, Brazil, 86015-610
- Rodrigo dos Reis Fernandes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: whey protein plus collagen group
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.
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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.
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PLACEBO_COMPARATOR: whey protein plus maltodextrin group
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body composition
Time Frame: baseline and after 12 weeks
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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.
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baseline and after 12 weeks
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Change in Muscular strength
Time Frame: baseline and after 12 weeks
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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
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baseline and after 12 weeks
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Change in knee cartilage
Time Frame: baseline and after 12 weeks
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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.
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baseline and after 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total cholesterol
Time Frame: 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.
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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.
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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.
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Change in high-density lipoprotein (HDL-C)
Time Frame: baseline and after 12 weeks
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Measurements of serum levels of high-density lipoprotein 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.
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baseline and after 12 weeks
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Change in triglycerides
Time Frame: baseline and after 12 weeks
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Measurements of serum levels of triglycerides 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.
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baseline and after 12 weeks
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Change in low-density lipoprotein
Time Frame: baseline and after 12 weeks
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For the determination of LDL-c was used the Friedewald equation: LDL-c=TC - (HDL-c + TG / 5).
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baseline and after 12 weeks
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Change in glucose
Time Frame: baseline and after 12 weeks
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Measurements of serum levels of glucose (GLU) were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring).
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baseline and after 12 weeks
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Change in insulin
Time Frame: baseline and after 12 weeks
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Insulin was determined by the chemiluminescence method (LIASON equipment)
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baseline and after 12 weeks
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Change in HOMA-IR
Time Frame: baseline and after 12 weeks
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The Homeostasis Assessment Model (HOMA-IR) was calculated by the formula: Insulin fasting (μUI / mL) x Glucose fasting (mmol / L) / 22.5.
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baseline and after 12 weeks
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Change in blood pressure
Time Frame: baseline and after 12 weeks
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Resting BP assessment was performed using automatic, oscillometric equipment (Omron - 7113).
Participants attended the laboratory on three different days and, during each visit, remained seated at rest for 10 min with the cuff of the equipment in place on the right arm.
Subsequently, several BP measurements were performed at one-minute intervals in order to obtain three consecutive measurements where the difference in systolic BP (SBP) and diastolic BP (DBP) readings differed by no more than 4 mmHg.
The average of the three measurements for each day was averaged across the three visits.
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baseline and after 12 weeks
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Change in body mass
Time Frame: baseline and after 12 weeks
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Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale, with subjects wearing light workout clothing and no shoes.
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baseline and after 12 weeks
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Change in height
Time Frame: baseline and after 12 weeks
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Height was measured using a stadiometer to the nearest 0.1 cm while subjects were standing without shoes.
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baseline and after 12 weeks
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Change in body mass index
Time Frame: baseline and after 12 weeks
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Body mass index was calculated as the body mass in kilograms divided by the square of the height in meters.
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baseline and after 12 weeks
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Change in waist circumference
Time Frame: baseline and after 12 weeks
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We also collected data on waist circumference (WC), using a flexible and inelastic tape measure.
WC was obtained at the midpoint between the last rib and the iliac crest at the time of expiration.
Two measurements were used to measure each circumference.
In situations in which the difference between the measurements was greater than 0.5 cm a third measurement was performed, with the value of the median being adopted as reference.
All measurements were performed by the same evaluator.
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baseline and after 12 weeks
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Change in hip circumference
Time Frame: baseline and after 12 weeks
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We also collected data on hip circumference, using a flexible and inelastic tape measure.
HC was measured in the region of greater perimeter between the waist and the thigh.
Two measurements were used to measure each circumference.
In situations in which the difference between the measurements was greater than 0.5 cm a third measurement was performed, with the value of the median being adopted as reference.
All measurements were performed by the same evaluator.
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baseline and after 12 weeks
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Dietary intake
Time Frame: baseline and after 12 weeks
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Food consumption were assessed by the 24-hour dietary recall method applied on two non-consecutive days of the week, with the aid of a photographic record taken during an interview.
The homemade measurements of the nutritional values of food and supplementation were converted into grams and milliliters by the online software Virtual Nutri Plus for diet analysis.
Some foods were not found in the program database and therefore items were added from food tables.
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baseline and after 12 weeks
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Change in inflammatory markers
Time Frame: baseline and after 12 weeks
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Tumor Necrosis Factor -α (TNF-α) and Interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer and performed in a microplate reader Perkin Elmer, model EnSpire (USA).
All samples were determined in duplicate to guarantee the precision of the results.
The results are presented in picograms per milliliter (pg/ml).
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baseline and after 12 weeks
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Change in hepatic markers
Time Frame: baseline and after 12 weeks
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Aspartate aminotrasferase(AST), Alanine aminotransferase(ALT) , were determined by enzimatic method (IFCC Technology: Cobas 6000 - Roche) and and Gamma glutamyl transferase(γ-GT) were determined by colorimetric enzimatic method(IFCC Technology: Cobas 6000 - Roche) according to the specifications of the manufacturer, All samples were determined in duplicate to guarantee the precision of the results.
The results are presented in units by liter (U/L).
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baseline and after 12 weeks
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Change in C-reactive protein (CRP)
Time Frame: baseline and after 12 weeks
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Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.
The results are presented in milligrams per decilitre (mg/dL).
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baseline and after 12 weeks
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Change in Uric acid
Time Frame: baseline and after 12 weeks
|
Uric acid , were determined by colorimetric enzimatic method (Technology: Cobas 6000 - Roche) according to the specifications of the manufacturer, All samples were determined in duplicate to guarantee the precision of the results.
The results are presented in miligrams by deciliter (mg/dL).
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baseline and after 12 weeks
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Change in Urea
Time Frame: baseline and after 12 weeks
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Uric acid, were determined by kinetic method (Technology: Cobas 6000 - Roche) according to the specifications of the manufacturer, All samples were determined in duplicate to guarantee the precision of the results.
The results are presented in miligrams by deciliter (mg/dL).
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baseline and after 12 weeks
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Change in Creatinine
Time Frame: baseline and after 12 weeks
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Creatinine, were determined by kinetic colorimetric method (Technology: Cobas 6000 - Roche) according to the specifications of the manufacturer, All samples were determined in duplicate to guarantee the precision of the results.
The results are presented in miligrams by deciliter (mg/dL).
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baseline and after 12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Edilson S Cyrino, PhD., Universidade Estadual de Londrina
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPMN2019/02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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