NCT03672786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

September 8, 2018

Last Update Submit

September 13, 2018

Conditions

Genetic ChangeAthlete

Keywords

Gene ExpressionAthletesMicronutrient InterventionWhole Blood

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (15)

  • Anthropometric assessment - Height

    6 months

  • Anthropometric assessment - Weight

    6 months

  • Anthropometric assessment - BMI

    6 months

  • Anthropometric assessment - Fat percentage

    6 months

  • Anthropometric assessment - Fat free mass

    6 months

  • +10 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Sedentary: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months

Dietary Supplement: Multicentrum

Experimental Group

EXPERIMENTAL

Athletes: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months

Dietary Supplement: Multicentrum

Interventions

MulticentrumDIETARY_SUPPLEMENT

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

Also known as: Multicentrum 2 months
Control GroupExperimental Group

Eligibility Criteria

Age20 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale, Adult
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

Location

Study Officials

  • Elena Planells, PhD

    Universidad de Granada

    STUDY DIRECTOR

  • Jorge Molina, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 14, 2018

Study Start

August 15, 2016

Primary Completion

April 3, 2017

Study Completion

September 3, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

ES(1)