Body WeightNCT03752359
Whey Protein Supplementation and Resistance Training in Older Women With Sarcopenic Obesity.
A study testing whey protein in people with Body Weight and Healthy, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
The main purpose of the present study was to investigate the effects of whey protein following resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Healthy
- What is being tested?
- whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Mar 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All subjects not participating in 85% of the total sessions of training or withdraw
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whey Protein Supplementation Combined With Resistance Training on Body Composition, Muscular Strength, Functional Capacity, and Plasma-metabolism Biomarkers in Older Women With Sarcopenic Obesity
The main purpose of the present study was to investigate the effects of whey protein following resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity.
Read the detailed description
This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two 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) 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 program. In this study, only women with SO were included. SO was defined as a body fat mass ≥ 35%(29) combined with appendicular lean soft tissue (ALST) less than <15.02 kg(30), 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.
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 was used to test data distribution. Data are presented as means, standard deviation, and z-score. The student's independent t-test and chi-square test were used to compare groups regarding the general characteristics and clinical/medical history (categorical variables). Two-way analysis of variance (ANOVA) for repeated measures was used to assess between group comparisons. The effect size (ES) was calculated to verify the magnitude of the differences by Cohen's d, where an ES of 0.20-0.49 was 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 was 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 was also applied. For all statistical analyses, significance was accepted at P < 0.05. The data were analyzed using SPSS software version 20.0 (SPSS, Inc., Chicago, IL, USA).
- Conditions
- Body Weight, Healthy
- Being tested
- whey protein, placebo
- Keywords
- sarcopenia, obesity, protein intake, IL-6, lean tissue
- Medical subject headings
- Body Weight, Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinDietary supplement
This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two 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) 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.
placeboDietary supplement
This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two 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) 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.
| Study group | Role | What they receive |
|---|---|---|
| whey protein group | Experimental | Participants received a dose of 35 grams of whey protein after resistance training (RT). 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. Receives: Dietary Supplement: whey protein |
| placebo group | Placebo comparator | Participants received a dose of 35 grams of maltodextrin after resistance training (RT). 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. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline and after 12 weeks
Secondary outcomes (17)
Change in inflammatory markers
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).
Measured: baseline and after 12 weeks
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).
Measured: baseline and after 12 weeks
Change in oxidative stress
For measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method. AOPP concentrations were expressed as micromoles per liter (μmol/L). Total plasma antioxidant capacity (TRAP) was determined by the chemiluminescence method for the induction time of 2.2 azo-bis (2-amidinopropane) and calibrated with Trolox analogue of vitamin E. TRAP values were expressed in μmol of Trolox.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
Change in low-density lipoprotein
For the determination of LDL-c was used the Friedewald equation: LDL-c=TC - (HDL-c + TG / 5).
Measured: baseline and after 12 weeks
Change in glucose
Measurements of serum levels of glucose (GLU) were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring).
Measured: baseline and after 12 weeks
Change in insulin
Insulin was determined by the chemiluminescence method (LIASON equipment)
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
Change in height
Height was measured using a stadiometer to the nearest 0.1 cm while subjects were standing without shoes.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
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.
Measured: baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start13 Mar 2017
- Primary completion17 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Principal investigator, Hellen Clair Garcêz Nabuco, Universidade Estadual de Londrina
- Investigators
- Edilson Cyrino, PhD., Study director, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752359
- Sponsor's protocol ID
- UEL1700756-1/2018
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19204579Kim 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.
PubMed 15090482Sardinha 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.
PubMed 9771855Nabuco HCG, Tomeleri CM, Fernandes RR, Sugihara Junior P, Cavalcante EF, Cunha PM, Antunes M, Nunes JP, Venturini D, Barbosa DS, Burini RC, Silva AM, Sardinha LB, Cyrino ES. Effect of whey protein supplementation combined with resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity: A randomized, double-blind, placebo-controlled trial. Clin Nutr ESPEN. 2019 Aug;32:88-95. doi: 10.1016/j.clnesp.2019.04.007. Epub 2019 May 13.
PubMed 31221297
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein Supplementation Combined With Resistance Training on Body Composition, Muscular Strength, Functional Capacity, and Plasma-metabolism Biomarkers in Older Women With Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT03752359
- Acronym / sponsor ID
- UEL1700756-1/2018
- Conditions
- Body Weight, Healthy
- Keywords
- sarcopenia, obesity, protein intake, IL-6, lean tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the present study was to investigate the effects of whey protein following resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity.
Detailed description
This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two 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) 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 program. In this study, only women with SO were included. SO was defined as a body fat mass ≥ 35%(29) combined with appendicular lean soft tissue (ALST) less than <15.02 kg(30), 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.
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 was used to test data distribution. Data are presented as means, standard deviation, and z-score. The student's independent t-test and chi-square test were used to compare groups regarding the general characteristics and clinical/medical history (categorical variables). Two-way analysis of variance (ANOVA) for repeated measures was used to assess between group comparisons. The effect size (ES) was calculated to verify the magnitude of the differences by Cohen's d, where an ES of 0.20-0.49 was 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 was 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 was also applied. For all statistical analyses, significance was accepted at P < 0.05. The data were analyzed using SPSS software version 20.0 (SPSS, Inc., Chicago, IL, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whey protein group | Experimental | Dietary Supplement: whey proteinParticipants received a dose of 35 grams of whey protein after resistance training (RT). 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. |
| placebo group | Placebo comparator | Dietary Supplement: placeboParticipants received a dose of 35 grams of maltodextrin after resistance training (RT). 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- All subjects not participating in 85% of the total sessions of training or withdraw
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey proteinThis two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two 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) 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. | Dietary supplement | whey protein group |
| placeboThis two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two 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) 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. | Dietary supplement | placebo group |
Primary outcome
Change in body composition
Time frame: baseline and after 12 weeks
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.
Change in Muscular strength
Time frame: baseline and after 12 weeks
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
17 secondary outcomes
Change in inflammatory markers
Time frame: baseline and after 12 weeks
Change in C-reactive protein (CRP)
Time frame: baseline and after 12 weeks
Change in oxidative stress
Time frame: baseline and after 12 weeks
Change in Total cholesterol
Time frame: baseline and after 12 weeks
Change in high-density lipoprotein (HDL-C)
Time frame: baseline and after 12 weeks
Change in triglycerides
Time frame: baseline and after 12 weeks
Change in low-density lipoprotein
Time frame: baseline and after 12 weeks
Change in glucose
Time frame: baseline and after 12 weeks
Change in insulin
Time frame: baseline and after 12 weeks
Change in HOMA-IR
Time frame: baseline and after 12 weeks
Change in blood pressure
Time frame: baseline and after 12 weeks
Change in body mass
Time frame: baseline and after 12 weeks
Change in height
Time frame: baseline and after 12 weeks
Change in body mass index
Time frame: baseline and after 12 weeks
Change in waist circumference
Time frame: baseline and after 12 weeks
Change in hip circumference
Time frame: baseline and after 12 weeks
Dietary intake
Time frame: baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Background: PubMed 19204579American 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.
- Background: PubMed 15090482Kim 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.
- Background: PubMed 9771855Sardinha 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.
- Derived from this study: PubMed 31221297Nabuco HCG, Tomeleri CM, Fernandes RR, Sugihara Junior P, Cavalcante EF, Cunha PM, Antunes M, Nunes JP, Venturini D, Barbosa DS, Burini RC, Silva AM, Sardinha LB, Cyrino ES. Effect of whey protein supplementation combined with resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity: A randomized, double-blind, placebo-controlled trial. Clin Nutr ESPEN. 2019 Aug;32:88-95. doi: 10.1016/j.clnesp.2019.04.007. Epub 2019 May 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edilson Cyrino, PhD. study director
Universidade Estadual de Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein in people with Body Weight and Healthy, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: baseline and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752359, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.