Clinical trial NCT03247192: Whey Protein Supplementation Associated With Resistance Training on Health Indicators in Trained Older Women
Official title: Effect of Whey Protein Supplementation Associated With Resistance Training on Body Composition, Cellular Hydration, Phase Angle, Muscle Strength, Glycemic and Lipid Profile, Inflammatory and Oxidative Stress Markers in Trained Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Healthy
Keywords: resistance training
protein supplementation
aging
Randomized Controlled Trial
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2017-08-11
Enrollment: 66
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 supplementation associated with resistance training on muscle strength, body composition, muscle quality, cellular hydration, cardiometabolic risk factors, inflammatory and oxidative stress markers in trained elderly women and to evaluate whether the timing of protein intake provide different responses on these variables.

Detailed description: This study was carried out over a period of 26 weeks divided in two phases. The first phase of the study was an eight-week period (weeks 3-10), during which subjects were familiarized to RT. This RT period was conducted to standardize training status, and to overcome strong neural adaptations known to occur within the first few weeks of RT. Phase 2, supplementation phase, the participants was randomized in three groups and started 12 weeks dedicated to supplementation plus RT (weeks 13-24). At the beginning and the end of each phase of the experiment, two weeks were allocated for evaluations (weeks 1-2, 11-12 and 25-26) consisting of anthropometric, body composition, one repetition maximum tests (1RM), phase angle, body water, blood samples and dietary intake measurements.

Recruitment was carried out through newspaper and radio advertising, and home delivery of leaflets in the central area and residential neighborhoods. All participants completed health history and physical activity questionnaires and met the following inclusion criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement and/or thyroid therapy, not using equipment that would prevent the accomplishment of protocols and tests, and not performing any regular physical exercise for 6 months preceding the beginning of the study. Participants have passed a diagnostic graded exercise stress test with 12-lead electrocardiogram reviewed by a cardiologist and were released with no restrictions for participation in this investigation. Eighty-three Brazilian older women (≥ 60 years old), volunteered to participate in this investigation. After individual interviews, thirteen volunteers were excluded because they did not meet the inclusion criteria. Seventy participants were submitted to a standardized resistance training (RT) program, for eight weeks. After the assessments, the participants were randomly divided into three groups according relative strength (ratio of total strength obtained on 1-RM tests by body mass): (1) whey protein pre- and placebo post- RT (whey protein-placebo, (2) placebo pre- and whey protein post- RT, and (3) placebo pre- and post- RT. A blinded researcher was responsible for generating random numbers for participant allocation. All groups were submitted to the same RT program and 66 participants completed the experiment. The reasons for withdrawal from the study was reported as personal reasons and transportation issues.

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 (nº 1.700.756).

The paired t-test was used to analyze the effects (pre- vs post-) of the first phase. Two-way analysis of variance for repeated measures was applied for intra- and inter-group comparisons. When the baseline was different (ANOVA one-way), two-way analysis of covariance (ANCOVA) for repeated measures was applied for comparisons, with baseline scores used as covariates. When an F-ratio was significant, Fisher's post hoc test was employed to identify mean differences. The statistical power was determined to verify the statistical power of the analysis. For all statistical analyses, significance was accepted at P\<0.05.

Eligibility criteria: Inclusion Criteria:

* 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation
* Participants passed 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 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in Phase Angle
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in cellular hydration
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in C-reactive protein (CRP)
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in inflammatory markers
timeFrame: Baseline and 12 weeks
measure: Change in CATALASE (CAT)
timeFrame: Baseline and 12 weeks
measure: Change in superoxide dismutase (SOD)
timeFrame: Baseline and 12 weeks
measure: Change in oxidative stress
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in lipid profile
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in glucose, insulin and HOMA-IR
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: change in Muscular strength
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
Secondary outcomes:
measure: Change in anthropometric measurements
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Change in blood pressure
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
measure: Dietary intake
timeFrame: baseline 1; after 8 weeks (baseline2) and after 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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