Clinical trial NCT03672786: Gene Expression in Intervened Athletes
Official title: Gene Expression in Nutritional Intervened Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Change
Athlete
Keywords: Gene Expression
Athletes
Micronutrient Intervention
Whole Blood
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University of La Laguna
First posted: 2018-09-14
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Exercise represents an important challenge for the homeostasis of the entire body that occurs on a cellular and systemic level in which micronutrients play an important role in regulating the processes that sustain athletic performance. Objective: The investigators measured changes in gene expression of whole blood in a group of athletes and sedentary participants and compared gene modulation before and after nutritional intervention with micronutrients. Methods: Blood samples were taken from thirteen athletes and thirteen sedentary age- and gender-matched participants. The study design was carried out over a period of 4 months where three time points were established: (T0) baseline conditions in the sedentary and athlete groups; (T2) after two months of supplementation; (T4) after two months in the absence of nutritional supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.

Detailed description: Background: Exercise represents an important challenge for the homeostasis of the entire body that occurs on a cellular and systemic level in which micronutrients play an important role in regulating the processes that sustain athletic performance. Objective: The investigators measured changes in gene expression of whole blood in elite athletes and sedentary subjects and compared gene modulation before and after nutritional intervention with micronutrients. Methods: Thirteen elite athletes and thirteen sedentary controls were enrolled in the present study. Blood samples were taken from athletes and sedentary age- and gender-matched subjects. The study design was carried out over a period of 4 months where three time points were established: (T0) baseline conditions in the sedentary and handball groups; (T2) after two months of supplementation; (T4) after two months in the absence of nutritional supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.

Eligibility criteria: Inclusion Criteria:

* To pass a recruitment medical examination consisting of a clinical examination and recording the participant's medical history.
* Non-smoker and not being on a medication regimen.
* Written informed consent prior to participation.
* With regard to the sedentary controls, none of the subjects reported at least 150 min·wk-1 of moderate-intensity or 75 min·wk-1 of vigorous-intensity aerobic physical activity necessary for substantial health benefits.
* With regard to athletes, to be involved in a training regime including both indoor exercise and integrated conditioning exercises in addition to competing in matches on weekends.

Primary outcomes:
measure: Gene expression analysis
timeFrame: 6 months
Secondary outcomes:
measure: Anthropometric assessment - Height
timeFrame: 6 months
measure: Anthropometric assessment - Weight
timeFrame: 6 months
measure: Anthropometric assessment - BMI
timeFrame: 6 months
measure: Anthropometric assessment - Fat percentage
timeFrame: 6 months
measure: Anthropometric assessment - Fat free mass
timeFrame: 6 months
measure: Anthropometric assessment - Muscle mass
timeFrame: 6 months
measure: Biochemical parameters - Glucose
timeFrame: At baseline
measure: Biochemical parameters - Creatinine
timeFrame: At baseline
measure: Biochemical parameters - Urea
timeFrame: At baseline
measure: Biochemical parameters - Uric acid
timeFrame: At baseline
measure: Biochemical parameters - Triglycerides
timeFrame: At baseline
measure: Biochemical parameters - Total cholesterol
timeFrame: At baseline
measure: Biochemical parameters - Total proteins
timeFrame: At baseline
measure: Biochemical parameters - Transferrin
timeFrame: At baseline
measure: Biochemical parameters - Albumin
timeFrame: At baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
affiliation: Universidad de Granada
name: Elena Planells, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Granada
name: Jorge Molina, PhD
role: PRINCIPAL_INVESTIGATOR
References: