Gene Expression in Intervened Athletes

Athlete Clinical Trial

Official title:

Gene Expression in Nutritional Intervened Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672786
• Other study ID #: PI10/1993
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: September 3, 2018

Study information

• Verified date: September 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 3, 2018
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athlete
• Genetic Change

Intervention

Dietary Supplement:
• Multicentrum
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 2 months

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	University of La Laguna

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression analysis	112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System. Relative quantification was determined using the 2-?CT method. Cut-off punctuation was established as 1.5.	6 months
Secondary	Anthropometric assessment - Height	Anthropometric assessment recorded data were height in centimetres (SECA® Model 274).	6 months
Secondary	Anthropometric assessment - Weight	Anthropometric assessment recorded data were weight in kilograms (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain).	6 months
Secondary	Anthropometric assessment - BMI	Anthropometric assessment recorded data BMI was calculated calculated as weight/height^2 and expressed kg/m2 equation.	6 months
Secondary	Anthropometric assessment - Fat percentage	Anthropometric assessment recorded data BMI was measured by multifrequency bioelectrical impedance (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain) and expressed in kilograms and as the percentage of body fat. Participants were informed in advance of the required conditions prior to the measurement: no alcohol less than 24 hours before the measurement, no vigorous exercise less than 12 hours prior to the measurement, no food or drink less than 3 hours prior to the measurement, and no urination immediately before the measurement. All measurements were taken simultaneously during the morning in fasting conditions.	6 months
Secondary	Anthropometric assessment - Fat free mass	Anthropometric assessment recorded data fat free mass was measured by multifrequency bioelectrical impedance (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain) and expressed in kilograms and as the percentage of fat-free mass. Participants were informed in advance of the required conditions prior to the measurement: no alcohol less than 24 hours before the measurement, no vigorous exercise less than 12 hours prior to the measurement, no food or drink less than 3 hours prior to the measurement, and no urination immediately before the measurement. All measurements were taken simultaneously during the morning in fasting conditions.	6 months
Secondary	Anthropometric assessment - Muscle mass	Anthropometric assessment recorded data muscle mass was measured by multifrequency bioelectrical impedance (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain) and expressed in kilograms. Participants were informed in advance of the required conditions prior to the measurement: no alcohol less than 24 hours before the measurement, no vigorous exercise less than 12 hours prior to the measurement, no food or drink less than 3 hours prior to the measurement, and no urination immediately before the measurement. All measurements were taken simultaneously during the morning in fasting conditions.	6 months
Secondary	Biochemical parameters - Glucose	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Glucose was measured and expressed in mg/dL. The reference value is established in 70 - 110 mg/dL.	At baseline
Secondary	Biochemical parameters - Creatinine	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Creatinine was measured and expressed in mg/dL. The reference value is established in 0.5 - 0.9 mg/dL.	At baseline
Secondary	Biochemical parameters - Urea	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Urea was measured and expressed in mg/dL. The reference value is established in 10 - 50 mg/dL.	At baseline
Secondary	Biochemical parameters - Uric acid	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Uric acid was measured and expressed in mg/dL. The reference value is established in 2.4 - 5.7 mg/dL.	At baseline
Secondary	Biochemical parameters - Triglycerides	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Triglycerides acid was measured and expressed in mg/dL. The reference value is established in 50 - 200 mg/dL.; total cholesterol (mg/dL), total proteins (g/dL), transferrin (mg/dL) and albumin (mg/dL).	At baseline
Secondary	Biochemical parameters - Total cholesterol	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Total cholesterol was measured and expressed in mg/dL. The reference value is established in 110 - 200 mg/dL.	At baseline
Secondary	Biochemical parameters - Total proteins	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Total proteins were measured and expressed in mg/dL. The reference value is established in 6.6 - 8.7 g/dL.	At baseline
Secondary	Biochemical parameters - Transferrin	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Transferrin was measured and expressed in mg/dL. The reference value is established in 200 - 360 mg/dL.	At baseline
Secondary	Biochemical parameters - Albumin	Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). Albumin was measured and expressed in mg/dL. The reference value is established in 3.5 - 5.2 mg/dL.	At baseline