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

NCT05052164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-09-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

BEHAVIORAL

Gluten-free nutrition plan group

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

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

Sponsors & Collaborators

  • University of Alicante

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-08-01
Completion
2021-09-01

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052164 on ClinicalTrials.gov