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.
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.
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.
- Conditions
- Genetic Change, Athlete
- 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 group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Sedentary: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months Receives: Dietary Supplement: Multicentrum |
| Experimental Group | Experimental | Athletes: 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.
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)
Anthropometric assessment - Height
Anthropometric assessment recorded data were height in centimetres (SECA® Model 274).
Measured: 6 months
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
Anthropometric assessment - BMI
Anthropometric assessment recorded data BMI was calculated calculated as weight/height^2 and expressed kg/m2 equation.
Measured: 6 months
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted14 Sep 2018
- Study start15 Aug 2016
- Primary completion3 Apr 2017
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of La Laguna
- Responsible party
- Principal investigator, Elena Planells del Pozo, Universidad de Granada
- Investigators
- Elena Planells, PhD, Study director, Universidad de GranadaJorge Molina, PhD, Principal investigator, Universidad de Granada
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression in Nutritional Intervened Athletes
- ClinicalTrials.gov ID
- NCT03672786
- Acronym / sponsor ID
- PI10/1993
- Conditions
- Genetic Change, Athlete
- Keywords
- Gene Expression, Athletes, Micronutrient Intervention, Whole Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of La Laguna
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Dietary Supplement: MulticentrumSedentary: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months |
| Experimental Group | Experimental | Dietary Supplement: MulticentrumAthletes: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MulticentrumAlso: Multicentrum 2 monthsThe multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 2 months | Dietary supplement | Control Group, Experimental Group |
Primary outcome
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.
15 secondary outcomes
Anthropometric assessment - Height
Time frame: 6 months
Anthropometric assessment - Weight
Time frame: 6 months
Anthropometric assessment - BMI
Time frame: 6 months
Anthropometric assessment - Fat percentage
Time frame: 6 months
Anthropometric assessment - Fat free mass
Time frame: 6 months
Anthropometric assessment - Muscle mass
Time frame: 6 months
Biochemical parameters - Glucose
Time frame: At baseline
Biochemical parameters - Creatinine
Time frame: At baseline
Biochemical parameters - Urea
Time frame: At baseline
Biochemical parameters - Uric acid
Time frame: At baseline
Biochemical parameters - Triglycerides
Time frame: At baseline
Biochemical parameters - Total cholesterol
Time frame: At baseline
Biochemical parameters - Total proteins
Time frame: At baseline
Biochemical parameters - Transferrin
Time frame: At baseline
Biochemical parameters - Albumin
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Planells, PhD study director
Universidad de Granada
Jorge Molina, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
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.