Clinical trial NCT05052164: Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
Official title: Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women. Effects Of Gluten-Free Diet And Physical Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Diet, Gluten-Free
Exercise
Resistance Training
Quality of Life
Body Composition
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 28
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Celiac disease (CD) is an immunological disorder that mainly affects the small intestine, generating an inflammatory process in response to the presence of gluten (a protein). Autoimmune diseases are part of a group of diseases that are difficult to diagnose without a specific protocol or consensus to detect them due to the number of symptoms and diseases with which it has a relationship. The incidence of CD in Spain -according to data from the rest of the European Economic Community, since there is no study on incidence in Spain- is assumed to be approximately 1 per 100 live births. It is more frequent in women, with a 2:1 ratio. The only treatment consists of a STRICT GLUTEN-FREE DIET FOR LIFE. This results in the disappearance of symptoms, normalization of serology and recovery of intestinal villi. Failure to follow the diet can lead to important complications which, especially in adulthood, can manifest themselves in the form of osteopenia, osteoporosis and a high risk of neoplasms in the digestive tract, mainly. The main objective is to achieve a physical and physiological improvement in menopausal or post-menopausal celiac women. The specific objectives will be to know the influence of a dietary-nutritional program combined with physical exercise in menopausal or post-menopausal celiac women on:

* Physical condition (strength, endurance, functional autonomy...).
* Body composition.
* Psychological aspects.
* Physiological parameters (heart rate, maximum oxygen consumption, blood analysis...).


Eligibility criteria: Inclusion Criteria:

* Women
* Over 40 years old
* Menopausal or post-menopausal women
* Women with celiac disease (in the case of the experimental groups)

Exclusion Criteria:

* Men
* Women of childbearing age
* Women \< 40 years old
* Failure to sign informed consent form

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: 12 weeks
measure: Body Composition - Fat Mass
timeFrame: 12 weeks
measure: Body Composition - Lean Body Mass
timeFrame: 12 weeks
measure: Body Composition - Visceral Fat
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Strength
timeFrame: 12 weeks
measure: Adherence to gluten-free diet
timeFrame: 12 weeks
measure: Anthropometric assessment - Skinfolds
timeFrame: 12 weeks
measure: Anthropometric assessment - Perimeters
timeFrame: 12 weeks
measure: Anthropometric assessment - Diameters
timeFrame: 12 weeks
measure: Anthropometric assessment - Height
timeFrame: 12 weeks
measure: Resistance test
timeFrame: 12 weeks
measure: Balance test
timeFrame: 12 weeks
measure: Functional autonomy test
timeFrame: 12 weeks
measure: State of mind
timeFrame: 12 weeks
measure: Eating disorders
timeFrame: 12 weeks
measure: Heart rate variability
timeFrame: 12 weeks
measure: Maximum oxygen consumption
timeFrame: 12 weeks
measure: Glucose in blood
timeFrame: 12 weeks
measure: Cholesterol in blood
timeFrame: 12 weeks
measure: Creatinine in blood
timeFrame: 12 weeks
measure: Urea in blood
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: University of Alicante
state: San Vicente Del Raspeig
Study officials:
References: