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

NCT ID: NCT05052164

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-09-01

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...).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gluten-free nutrition plan + exercise group

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

Group Type: EXPERIMENTAL

Gluten-free nutrition plan + exercise group

Intervention Type: BEHAVIORAL

Menopausal 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

Gluten-free nutrition plan group

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

Group Type: EXPERIMENTAL

Gluten-free nutrition plan group

Intervention Type: BEHAVIORAL

Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program

Celiac controls group

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

Group Type: ACTIVE_COMPARATOR

Active Comparator: Celiac controls group

Intervention Type: BEHAVIORAL

Menopausal 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

Non-celiac controls group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gluten-free nutrition plan + exercise group

Menopausal 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

Intervention Type: BEHAVIORAL

Gluten-free nutrition plan group

Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program

Intervention Type: BEHAVIORAL

Active Comparator: Celiac controls group

Menopausal 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alicante

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Alejandro Martínez-Rodríguez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alicante

Alicante, San Vicente Del Raspeig, Spain

Countries

Spain

Other Identifiers

UA-2018-10-22

Identifier Type: -

Identifier Source: org_study_id