Clinical trial NCT03752359: Whey Protein Supplementation and Resistance Training in Older Women With Sarcopenic Obesity.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Healthy
Keywords: sarcopenia
obesity
protein intake
IL-6
lean tissue
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordination for the Improvement of Higher Education Personnel
First posted: 2018-11-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in body composition
timeFrame: baseline and after 12 weeks
measure: Change in Muscular strength
timeFrame: baseline and after 12 weeks
Secondary outcomes:
measure: Change in inflammatory markers
timeFrame: baseline and after 12 weeks
measure: Change in C-reactive protein (CRP)
timeFrame: baseline and after 12 weeks
measure: Change in oxidative stress
timeFrame: baseline and after 12 weeks
measure: Change in Total cholesterol
timeFrame: baseline and after 12 weeks
measure: Change in high-density lipoprotein (HDL-C)
timeFrame: baseline and after 12 weeks
measure: Change in triglycerides
timeFrame: baseline and after 12 weeks
measure: Change in low-density lipoprotein
timeFrame: baseline and after 12 weeks
measure: Change in glucose
timeFrame: baseline and after 12 weeks
measure: Change in insulin
timeFrame: baseline and after 12 weeks
measure: Change in HOMA-IR
timeFrame: baseline and after 12 weeks
measure: Change in blood pressure
timeFrame: baseline and after 12 weeks
measure: Change in body mass
timeFrame: baseline and after 12 weeks
measure: Change in height
timeFrame: baseline and after 12 weeks
measure: Change in body mass index
timeFrame: baseline and after 12 weeks
measure: Change in waist circumference
timeFrame: baseline and after 12 weeks
measure: Change in hip circumference
timeFrame: baseline and after 12 weeks
measure: Dietary intake
timeFrame: baseline and after 12 weeks
Other outcomes:
Locations:
city: Cuiabá
country: Brazil
facility: Hellen Clair Garcez Nabuco
state: Mount
Study officials:
affiliation: Universidade Estadual de Londrina
name: Edilson Cyrino, PhD.
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1152/japplphysiol.00260.2004. Epub 2004 Apr 16.
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. doi: 10.1093/ajcn/68.4.786.
citation: Nabuco 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.