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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05052164
Other study ID # UA-2018-10-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date September 1, 2021

Study information

Verified date September 2021
Source University of Alicante
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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...).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 70 Years
Eligibility 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

Study Design


Intervention

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
Gluten-free nutrition plan group
Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
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

Locations

Country Name City State
Spain University of Alicante Alicante San Vicente Del Raspeig

Sponsors (1)

Lead Sponsor Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

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