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

Study Overview
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Brief Summary
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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...).

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

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

Intervention / Treatment
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* Behavioral: Gluten-free nutrition plan + exercise group
* Behavioral: Gluten-free nutrition plan group
* Behavioral: Active Comparator: Celiac controls group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluten-free nutrition plan + exercise group<br>Celiac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan. | Behavioral: Gluten-free nutrition plan + exercise group<br>* 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<br>|
| Experimental: Gluten-free nutrition plan group<br>Women with celiac disease following a gluten-free isocaloric dietary plan. | Behavioral: Gluten-free nutrition plan group<br>* Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program<br>|
| Active Comparator: Celiac controls group<br>Women with celiac disease in whom all variables are measured but no intervention is performed. | Behavioral: Active Comparator: Celiac controls group<br>* 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<br>|
| No Intervention: Non-celiac controls group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL) | A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization | 12 weeks | 
| Body Composition - Fat Mass | Evaluation of body fat by bioimpedance. | 12 weeks | 
| Body Composition - Lean Body Mass | Evaluation of lean body mass by bioimpedance. | 12 weeks | 
| Body Composition - Visceral Fat | Evaluation of visceral fat by bioimpedance. | 12 weeks | 
| Weight | Weight evaluation using a digital scale | 12 weeks | 
| Strength | A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS) | 12 weeks | 
| Adherence to gluten-free diet | Questionnaire Adherence to gluten-free diet was performed. | 12 weeks | 
| Anthropometric assessment - Skinfolds | Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out. | 12 weeks | 
| Anthropometric assessment - Perimeters | Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out. | 12 weeks | 
| Anthropometric assessment - Diameters | Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out. | 12 weeks | 
| Anthropometric assessment - Height | Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out. | 12 weeks | 
| Resistance test | 6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test. | 12 weeks | 
| Balance test | By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports. | 12 weeks | 
| Functional autonomy test | GDLAM protocol | 12 weeks | 
| State of mind | Evaluation by using the Profile of Mood States POMS questionnaire. | 12 weeks | 
| Eating disorders | Eating disorders questionnaire: Eating Attitudes Test Questionnaire (EAT) in its 26-item version (EAT-26) in Spanish (Rivas et al., 2010). | 12 weeks | 
| Heart rate variability | Using novel Firstbeat Bodyguard device (Föhr, 2016) | 12 weeks | 
| Maximum oxygen consumption | Heart rate measurement and recording with Firsbeat Bodyguard | 12 weeks | 
| Glucose in blood | Glucose by blood test | 12 weeks | 
| Cholesterol in blood | Cholesterol by blood test | 12 weeks | 
| Creatinine in blood | Creatinine by blood test | 12 weeks | 
| Urea in blood | Urea by blood test | 12 weeks |