An interventional study of Gluten-free nutrition plan + exercise group and Gluten-free nutrition plan group in Celiac Disease, Diet, Gluten-Free and Exercise, sponsored by University of Alicante. Completed at 1 site in Spain. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by University of Alicante · Not applicable, Interventional, and Treatment
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:
333 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →University of Alicante is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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
Women with celiac disease following a gluten-free isocaloric dietary plan.
Behavioral: Gluten-free nutrition plan group
Women with celiac disease in whom all variables are measured but no intervention is performed.
Behavioral: Active Comparator: 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
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
Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
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
Quality of Life (QoL)
A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization
Time frame: 12 weeks
Body Composition - Fat Mass
Evaluation of body fat by bioimpedance.
Time frame: 12 weeks
Body Composition - Lean Body Mass
Evaluation of lean body mass by bioimpedance.
Time frame: 12 weeks
Body Composition - Visceral Fat
Evaluation of visceral fat by bioimpedance.
Time frame: 12 weeks
Weight
Weight evaluation using a digital scale
Time frame: 12 weeks
Strength
A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)
Time frame: 12 weeks
Adherence to gluten-free diet
Questionnaire "Adherence to gluten-free diet" was performed.
Time frame: 12 weeks
Anthropometric assessment - Skinfolds
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time frame: 12 weeks
Anthropometric assessment - Perimeters
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time frame: 12 weeks
Anthropometric assessment - Diameters
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time frame: 12 weeks
Anthropometric assessment - Height
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time frame: 12 weeks
Resistance test
6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.
Time frame: 12 weeks
Balance test
By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports.
Time frame: 12 weeks
Functional autonomy test
GDLAM protocol
Time frame: 12 weeks
State of mind
Evaluation by using the Profile of Mood States POMS questionnaire.
Time frame: 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).
Time frame: 12 weeks
Heart rate variability
Using novel Firstbeat Bodyguard device (Föhr, 2016)
Time frame: 12 weeks
Maximum oxygen consumption
Heart rate measurement and recording with Firsbeat Bodyguard
Time frame: 12 weeks
Glucose in blood
Glucose by blood test
Time frame: 12 weeks
Cholesterol in blood
Cholesterol by blood test
Time frame: 12 weeks
Creatinine in blood
Creatinine by blood test
Time frame: 12 weeks
Urea in blood
Urea by blood test
Time frame: 12 weeks
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Alicante