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Trials / Completed

CompletedNCT05052164

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

Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women. Effects Of Gluten-Free Diet And Physical Exercise

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
University of Alicante · Academic / Other
Sex
Female
Age
40 Years – 70 Years
Healthy volunteers
Accepted

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...).

Conditions

Interventions

TypeNameDescription
BEHAVIORALGluten-free nutrition plan + exercise groupMenopausal or post-menopausal celiac women will follow a physical exercise program 3/4 times per week and their dietary intake will be gluten-free isocaloric
BEHAVIORALGluten-free nutrition plan groupMenopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
BEHAVIORALActive Comparator: Celiac controls groupMenopausal or post-menopausal celiac women 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

Timeline

Start date
2018-09-01
Primary completion
2021-08-01
Completion
2021-09-01
First posted
2021-09-22
Last updated
2021-09-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05052164. Inclusion in this directory is not an endorsement.