Gene Expression in Intervened Athletes

September 13, 2018 updated by: Elena Planells del Pozo, Universidad de Granada

Gene Expression in Nutritional Intervened Athletes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Universidad de Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Multicentrum 2 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric assessment - Height
Time Frame: 6 months
Anthropometric assessment recorded data were height in centimetres (SECA® Model 274).
6 months
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).
6 months
Anthropometric assessment - BMI
Time Frame: 6 months
Anthropometric assessment recorded data BMI was calculated calculated as weight/height^2 and expressed kg/m2 equation.
6 months
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.
6 months
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 months
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.
6 months
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.
At baseline
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.
At baseline
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.
At baseline
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.
At baseline
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).
At baseline
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.
At baseline
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.
At baseline
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.
At baseline
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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of La Laguna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jorge Molina, PhD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI10/1993

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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