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Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition.

Primary Purpose

Female Athlete Triad, Energy Deficit Syndrome, Mediterranean Diet

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Free use of the virtual platform.
Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.
Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.
Sponsored by
University of Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Female Athlete Triad

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • (a) exercise at least 3 days/week,
  • (b) not having any diagnosed chronic pathology or ailment that prevents physical exercise or following nutritional guidelines rich in antioxidants.

Exclusion Criteria:

- All individuals taking medication that could affect the results of the study will be excluded from the study.

Sites / Locations

  • Alejandro Martínez RodriguezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Control group with free use of the virtual platform

Intervention group with Mediterranean diet and physical exercise planning

Intervention group with red berries and physical exercise planning

Arm Description

Will receive basic recommendations from the World Health Organization on healthy eating and physical activity.

The athletes, in addition to the recommendations indicated in the previous point, will have access to the virtual platform designed to voluntarily record the parameters they consider appropriate.

They will receive nutritional plans adapted to their energy expenditure and based on Mediterranean diet. The physical exercise intervention will be based on 3 weekly sessions of 50 minutes of combined resistance and strength, deferred.

They will also receive personalized nutritional plans with a diet rich in antioxidants obtained from red berries and the same physical exercise intervention as in the Mediterranean diet intervention group.

Outcomes

Primary Outcome Measures

Oxidative stress
Measurement of oxidative stress by pentane by exhaled air
Weight
Weight evaluation using a digital scale
Anthropometric assessment - Height
Restricted profile proposed by the International Society for the Development of Cineanthropometry.
Fat mass
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Muscular mass
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Bone mass
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Hydratation
Urine density will be measured with Refractometer.
Menstrual cycle
Using the Relative Energy Deficiency in Sport (RED-S) Clinical Assessment Tool (CAT) questionnaire. It is a clinical assessment tool for the evaluation of athletes / active individuals suspected of having relative energy deficiency and for guiding return to play decisions.
Gastrointestinal symptoms
The questionnaire on irritable bowel syndrome and symptom management among endurance athletes will be used; https://pubmed.ncbi.nlm.nih.gov/30232638/
Maximal oxygen uptake (VO2 max.)
In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Blood pressure
Using an OMROM upper arm blood pressure monitor.
Cholesterol in blood
Cholesterol by blood test
Strength
All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Creatin-Kinase in blood
Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Perception of quality of life
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Mood state
Profile of Mood State Questionnaire (POMS). The POMS questionnaire assesses six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. High vigor scores reflect a good mood or emotion, and low scores in the other subscales reflect a good mood or emotion.
Eating behavior
Eating Behavior Questionnaire (EAT-26). It is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. There are 26 self-report questions assessing general eating behaviour and five additional questions assessing risky behaviours. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder. Total scores 20 or above are considered to be in the clinical range.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2022
Last Updated
October 5, 2022
Sponsor
University of Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT05567211
Brief Title
Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition.
Official Title
Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition: Oxidative Stress and Other Physiological, Physical and Psychological Alterations.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Energy Deficit Syndrome (RED-S) is the impairment of physiological functioning caused by relative energy deficiency and includes impaired metabolic rate, menstrual, endocrine, hematological, immunological, gastrointestinal, bone, psychological, developmental and cardiovascular function. Eighty-seven percent of athletes show at least one symptom related to RED-S, with a higher prevalence in women. Treatment of RED-S preferably involves a multidisciplinary team of health professionals to address the complex interaction of nutrition, training, body image and performance. The main objective is to prevent energy deficit syndrome in female athletes in the province of Alicante through different training and diet protocols using a virtual platform. A 12-week single-blind randomized clinical trial with an intervention period and a control period (RCT) is proposed. The sports federations of the most representative practices in the province of Alicante will be selected by randomized sampling. The female athletes will be randomly divided into 4 groups (control group; control group with free use of the virtual platform; intervention group with Mediterranean diet and physical exercise planning; intervention group with red fruits and physical exercise planning).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Athlete Triad, Energy Deficit Syndrome, Mediterranean Diet, Red Fruits, Antioxidative Stress, Nutritional Disorder, Sports Physical Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Will receive basic recommendations from the World Health Organization on healthy eating and physical activity.
Arm Title
Control group with free use of the virtual platform
Arm Type
Placebo Comparator
Arm Description
The athletes, in addition to the recommendations indicated in the previous point, will have access to the virtual platform designed to voluntarily record the parameters they consider appropriate.
Arm Title
Intervention group with Mediterranean diet and physical exercise planning
Arm Type
Active Comparator
Arm Description
They will receive nutritional plans adapted to their energy expenditure and based on Mediterranean diet. The physical exercise intervention will be based on 3 weekly sessions of 50 minutes of combined resistance and strength, deferred.
Arm Title
Intervention group with red berries and physical exercise planning
Arm Type
Active Comparator
Arm Description
They will also receive personalized nutritional plans with a diet rich in antioxidants obtained from red berries and the same physical exercise intervention as in the Mediterranean diet intervention group.
Intervention Type
Other
Intervention Name(s)
Free use of the virtual platform.
Intervention Description
Access to the virtual platform + general healthy eating and physical activity recommendations. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood.
Intervention Type
Other
Intervention Name(s)
Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.
Intervention Description
Access to the virtual platform + nutritional planning based on the Mediterranean diet + physical activity. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood.
Intervention Type
Other
Intervention Name(s)
Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.
Intervention Description
Access to the virtual platform + nutritional planning with an extra supply of antioxidants using red berries + physical activity. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood.
Primary Outcome Measure Information:
Title
Oxidative stress
Description
Measurement of oxidative stress by pentane by exhaled air
Time Frame
12 weeks
Title
Weight
Description
Weight evaluation using a digital scale
Time Frame
12 weeks
Title
Anthropometric assessment - Height
Description
Restricted profile proposed by the International Society for the Development of Cineanthropometry.
Time Frame
12 weeks
Title
Fat mass
Description
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Time Frame
12 weeks
Title
Muscular mass
Description
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Time Frame
12 weeks
Title
Bone mass
Description
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Time Frame
12 weeks
Title
Hydratation
Description
Urine density will be measured with Refractometer.
Time Frame
12 weeks
Title
Menstrual cycle
Description
Using the Relative Energy Deficiency in Sport (RED-S) Clinical Assessment Tool (CAT) questionnaire. It is a clinical assessment tool for the evaluation of athletes / active individuals suspected of having relative energy deficiency and for guiding return to play decisions.
Time Frame
12 weeks
Title
Gastrointestinal symptoms
Description
The questionnaire on irritable bowel syndrome and symptom management among endurance athletes will be used; https://pubmed.ncbi.nlm.nih.gov/30232638/
Time Frame
12 weeks
Title
Maximal oxygen uptake (VO2 max.)
Description
In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Time Frame
12 weeks
Title
Blood pressure
Description
Using an OMROM upper arm blood pressure monitor.
Time Frame
12 weeks
Title
Cholesterol in blood
Description
Cholesterol by blood test
Time Frame
12 weeks
Title
Strength
Description
All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Time Frame
12 weeks
Title
Creatin-Kinase in blood
Description
Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Time Frame
12 weeks
Title
Perception of quality of life
Description
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
12 weeks
Title
Mood state
Description
Profile of Mood State Questionnaire (POMS). The POMS questionnaire assesses six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. High vigor scores reflect a good mood or emotion, and low scores in the other subscales reflect a good mood or emotion.
Time Frame
12 weeks
Title
Eating behavior
Description
Eating Behavior Questionnaire (EAT-26). It is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. There are 26 self-report questions assessing general eating behaviour and five additional questions assessing risky behaviours. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder. Total scores 20 or above are considered to be in the clinical range.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (a) exercise at least 3 days/week, (b) not having any diagnosed chronic pathology or ailment that prevents physical exercise or following nutritional guidelines rich in antioxidants. Exclusion Criteria: - All individuals taking medication that could affect the results of the study will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALEJANDRO MARTINEZ, Nutrition and Dietetics.
Phone
696210163
Email
amartinezrodriguez@gcloud.ua.es
Facility Information:
Facility Name
Alejandro Martínez Rodriguez
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALEJANDRO MARTINEZ RODRIGUEZ
Phone
696210163

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition.

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