Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition: Oxidative Stress and Other Physiological, Physical and Psychological Alterations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Menstrual cycle
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •All individuals taking medication that could affect the results of the study will be excluded from the study.
研究组 & 干预措施
Control group
Will receive basic recommendations from the World Health Organization on healthy eating and physical activity.
Control group with free use of the virtual platform
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.
干预措施: Free use of the virtual platform. (Other)
Intervention group with Mediterranean diet and physical exercise planning
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.
干预措施: Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application. (Other)
Intervention group with red berries and physical exercise planning
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.
干预措施: Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application. (Other)
结局指标
主要结局
Menstrual cycle
时间窗: 12 weeks
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
时间窗: 12 weeks
The questionnaire on irritable bowel syndrome and symptom management among endurance athletes will be used; https://pubmed.ncbi.nlm.nih.gov/30232638/
Mood state
时间窗: 12 weeks
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
时间窗: 12 weeks
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.
Fat mass
时间窗: 12 weeks
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Hydratation
时间窗: 12 weeks
Urine density will be measured with Refractometer.
Oxidative stress
时间窗: 12 weeks
Measurement of oxidative stress by pentane by exhaled air
Muscular mass
时间窗: 12 weeks
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Bone mass
时间窗: 12 weeks
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Anthropometric assessment - Height
时间窗: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry.
Cholesterol in blood
时间窗: 12 weeks
Cholesterol by blood test
Creatin-Kinase in blood
时间窗: 12 weeks
Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Weight
时间窗: 12 weeks
Weight evaluation using a digital scale
Maximal oxygen uptake (VO2 max.)
时间窗: 12 weeks
In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Strength
时间窗: 12 weeks
All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Perception of quality of life
时间窗: 12 weeks
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.
Blood pressure
时间窗: 12 weeks
Using an OMROM upper arm blood pressure monitor.
次要结局
未报告次要终点
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Full Professor
University of Alicante