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Genetic ChangeNCT03672786

Gene Expression in Intervened Athletes

A study testing Multicentrum in people with Genetic Change and Athlete, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for
Genetic Change, Athlete
What is being tested?
Multicentrum
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSpain
Study dates
15 Aug 2016to 3 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 25 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad de Granada

    Granada, 18071

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Multicentrum
Keywords
Gene Expression, Athletes, Micronutrient Intervention, Whole Blood

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MulticentrumDietary supplement

    Also called Multicentrum 2 months

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

Study groups in NCT03672786
Study groupRoleWhat they receive
Control GroupActive comparatorSedentary: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months
Receives: Dietary Supplement: Multicentrum
Experimental GroupExperimentalAthletes: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months
Receives: Dietary Supplement: Multicentrum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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-ΔCT method. Cut-off punctuation was established as 1.5.

    Measured: 6 months

Secondary outcomes (15)
  1. Anthropometric assessment - Height

    Anthropometric assessment recorded data were height in centimetres (SECA® Model 274).

    Measured: 6 months

  2. Anthropometric assessment - Weight

    Anthropometric assessment recorded data were weight in kilograms (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain).

    Measured: 6 months

  3. Anthropometric assessment - BMI

    Anthropometric assessment recorded data BMI was calculated calculated as weight/height^2 and expressed kg/m2 equation.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 6 months

  7. 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.

    Measured: At baseline

  8. 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.

    Measured: At baseline

  9. 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.

    Measured: At baseline

  10. 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.

    Measured: At baseline

  11. 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).

    Measured: At baseline

  12. 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.

    Measured: At baseline

  13. 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.

    Measured: At baseline

  14. 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.

    Measured: At baseline

  15. 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.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start15 Aug 2016
  3. Primary completion3 Apr 2017
  4. Study completion3 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672786
Sponsor's protocol ID
PI10/1993
Status last verified
Sep 2018
First submitted
8 Sep 2018
Last updated
14 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Multicentrum in people with Genetic Change and Athlete, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression analysis (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.

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