Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women

University of Alicante

Status: Completed

Conditions: Celiac Disease; Quality of Life; Diet, Gluten-Free; Resistance Training; Body Composition; Exercise

Treatments: Behavioral: Gluten-free nutrition plan + exercise group; Behavioral: Active Comparator: Celiac controls group; Behavioral: Gluten-free nutrition plan group

Study type: Interventional

Funder types: Other

Identifiers

NCT05052164

UA-2018-10-22

Details and patient eligibility

About

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...).

Enrollment: 28 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 4 patient groups

Gluten-free nutrition plan + exercise group

Experimental group

Description:

Celiac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan.

Treatment:

Behavioral: Gluten-free nutrition plan + exercise group

Gluten-free nutrition plan group

Experimental group

Description:

Women with celiac disease following a gluten-free isocaloric dietary plan.

Treatment:

Behavioral: Gluten-free nutrition plan group

Celiac controls group

Active Comparator group

Description:

Women with celiac disease in whom all variables are measured but no intervention is performed.

Treatment:

Behavioral: Active Comparator: Celiac controls group

Non-celiac controls group

No Intervention group

Description:

Non celiac menopausal or post-menopausal in whom all the tests were measured but they did not perform an intervention program with physical exercise or special follow-up of an adapted dietary-nutritional program