Sarcopenia Clinical Trial
Official title:
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
Verified date | November 2020 |
Source | Universidade Estadual de Londrina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 67 |
Est. completion date | December 4, 2019 |
Est. primary completion date | July 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 60 Years and older |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
Brazil | Rodrigo dos Reis Fernandes | Londrina | PR |
Lead Sponsor | Collaborator |
---|---|
Universidade Estadual de Londrina | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel, Rousselot BVBA |
Brazil,
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. Review. — View Citation
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. Epub 2004 Apr 16. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | 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. | |
Secondary | Change in high-density lipoprotein (HDL-C) | 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. | baseline and after 12 weeks | |
Secondary | Change in triglycerides | 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. | baseline and after 12 weeks | |
Secondary | Change in low-density lipoprotein | For the determination of LDL-c was used the Friedewald equation: LDL-c=TC - (HDL-c + TG / 5). | baseline and after 12 weeks | |
Secondary | Change in glucose | Measurements of serum levels of glucose (GLU) were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring). | baseline and after 12 weeks | |
Secondary | Change in insulin | Insulin was determined by the chemiluminescence method (LIASON equipment) | baseline and after 12 weeks | |
Secondary | Change in HOMA-IR | The Homeostasis Assessment Model (HOMA-IR) was calculated by the formula: Insulin fasting (µUI / mL) x Glucose fasting (mmol / L) / 22.5. | baseline and after 12 weeks | |
Secondary | Change in blood pressure | 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. | baseline and after 12 weeks | |
Secondary | Change in body mass | Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale, with subjects wearing light workout clothing and no shoes. | baseline and after 12 weeks | |
Secondary | Change in height | Height was measured using a stadiometer to the nearest 0.1 cm while subjects were standing without shoes. | baseline and after 12 weeks | |
Secondary | Change in body mass index | Body mass index was calculated as the body mass in kilograms divided by the square of the height in meters. | baseline and after 12 weeks | |
Secondary | Change in waist circumference | 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. | baseline and after 12 weeks | |
Secondary | Change in hip circumference | 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. | baseline and after 12 weeks | |
Secondary | Dietary intake | 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. | baseline and after 12 weeks | |
Secondary | Change in inflammatory markers | Tumor Necrosis Factor -a (TNF-a) 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). | baseline and after 12 weeks | |
Secondary | Change in hepatic markers | Aspartate aminotrasferase(AST), Alanine aminotransferase(ALT) , were determined by enzimatic method (IFCC Technology: Cobas 6000 - Roche) and and Gamma glutamyl transferase(?-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). | baseline and after 12 weeks | |
Secondary | Change in C-reactive protein (CRP) | 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). | baseline and after 12 weeks | |
Secondary | Change in Uric acid | 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). | baseline and after 12 weeks | |
Secondary | Change in Urea | 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). | baseline and after 12 weeks | |
Secondary | Change in Creatinine | 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). | baseline and after 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
Recruiting |
NCT05063279 -
RELIEF - Resistance Training for Life
|
N/A | |
Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
Recruiting |
NCT06143592 -
Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly
|
N/A | |
Terminated |
NCT04350762 -
Nutritional Supplementation in the Elderly With Weight Loss
|
N/A | |
Enrolling by invitation |
NCT05953116 -
Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study
|
N/A | |
Recruiting |
NCT04028206 -
Resistance Exercise or Vibration With HMB for Sarcopenia
|
N/A | |
Enrolling by invitation |
NCT03297632 -
Improving Muscle Strength, Mass and Physical Function in Older Adults
|
N/A | |
Completed |
NCT04015479 -
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
|
N/A | |
Completed |
NCT03234920 -
Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation
|
N/A | |
Recruiting |
NCT03998202 -
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
|
||
Recruiting |
NCT04717869 -
Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
|
||
Completed |
NCT05497687 -
Strength-building Lifestyle-integrated Intervention
|
N/A | |
Completed |
NCT03119610 -
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
|
Phase 1/Phase 2 | |
Recruiting |
NCT05711095 -
The Anabolic Properties of Fortified Plant-based Protein in Older People
|
N/A | |
Recruiting |
NCT05008770 -
Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
|
||
Not yet recruiting |
NCT05860556 -
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
|
||
Recruiting |
NCT04522609 -
Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
|
N/A | |
Recruiting |
NCT04545268 -
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
|
N/A | |
Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|