Clinical trial NCT05567211: 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
Overall status: COMPLETED
Phase: NA
Conditions: Female Athlete Triad
Energy Deficit Syndrome
Mediterranean Diet
Red Fruits
Antioxidative Stress
Nutritional Disorder
Sports Physical Therapy
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: Oxidative stress
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Anthropometric assessment - Height
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Muscular mass
timeFrame: 12 weeks
measure: Bone mass
timeFrame: 12 weeks
measure: Hydratation
timeFrame: 12 weeks
measure: Menstrual cycle
timeFrame: 12 weeks
measure: Gastrointestinal symptoms
timeFrame: 12 weeks
measure: Maximal oxygen uptake (VO2 max.)
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Cholesterol in blood
timeFrame: 12 weeks
measure: Strength
timeFrame: 12 weeks
measure: Creatin-Kinase in blood
timeFrame: 12 weeks
measure: Perception of quality of life
timeFrame: 12 weeks
measure: Mood state
timeFrame: 12 weeks
measure: Eating behavior
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Alejandro Martínez Rodriguez
state: Alicante
Study officials:
References: