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Gene Expression in Intervened Athletes

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ClinicalTrials.gov Identifier: NCT03672786
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
University of La Laguna
Information provided by (Responsible Party):
Elena Planells del Pozo, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Genetic Change Athlete Dietary Supplement: Multicentrum Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Gene Expression in Nutritional Intervened Athletes
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : April 3, 2017
Actual Study Completion Date : September 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Sedentary: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months
Dietary Supplement: Multicentrum
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 2 months
Other Name: Multicentrum 2 months

Experimental: Experimental Group
Athletes: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months
Dietary Supplement: Multicentrum
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 2 months
Other Name: Multicentrum 2 months




Primary Outcome Measures :
  1. Gene expression analysis [ Time Frame: 6 months ]
    112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System. Relative quantification was determined using the 2-ΔCT method. Cut-off punctuation was established as 1.5.


Secondary Outcome Measures :
  1. Anthropometric assessment - Height [ Time Frame: 6 months ]
    Anthropometric assessment recorded data were height in centimetres (SECA® Model 274).

  2. Anthropometric assessment - Weight [ Time Frame: 6 months ]
    Anthropometric assessment recorded data were weight in kilograms (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain).

  3. Anthropometric assessment - BMI [ Time Frame: 6 months ]
    Anthropometric assessment recorded data BMI was calculated calculated as weight/height^2 and expressed kg/m2 equation.

  4. Anthropometric assessment - Fat percentage [ Time Frame: 6 months ]
    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.

  5. Anthropometric assessment - Fat free mass [ Time Frame: 6 months ]
    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. Anthropometric assessment - Muscle mass [ Time Frame: 6 months ]
    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.

  7. Biochemical parameters - Glucose [ Time Frame: At baseline ]
    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.

  8. Biochemical parameters - Creatinine [ Time Frame: At baseline ]
    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.

  9. Biochemical parameters - Urea [ Time Frame: At baseline ]
    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.

  10. Biochemical parameters - Uric acid [ Time Frame: At baseline ]
    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.

  11. Biochemical parameters - Triglycerides [ Time Frame: At baseline ]

    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).


  12. Biochemical parameters - Total cholesterol [ Time Frame: At baseline ]
    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.

  13. Biochemical parameters - Total proteins [ Time Frame: At baseline ]
    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.

  14. Biochemical parameters - Transferrin [ Time Frame: At baseline ]
    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.

  15. Biochemical parameters - Albumin [ Time Frame: At baseline ]
    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.



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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male, Adult
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672786


Locations
Spain
Universidad de Granada
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
University of La Laguna
Investigators
Study Director: Elena Planells, PhD Universidad de Granada
Principal Investigator: Jorge Molina, PhD Universidad de Granada

Responsible Party: Elena Planells del Pozo, University Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03672786     History of Changes
Other Study ID Numbers: PI10/1993
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elena Planells del Pozo, Universidad de Granada:
Gene Expression
Athletes
Micronutrient Intervention
Whole Blood