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

Not Applicable

Completed

• Conditions: Quality of Life; Diet, Gluten-Free; Resistance Training; Body Composition; Celiac Disease; Exercise
• Interventions: Behavioral: Gluten-free nutrition plan + exercise group; Behavioral: Gluten-free nutrition plan group

• Registration Number: NCT05052164
• Lead Sponsor: University of Alicante

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...).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2021-08-01
• Status Verified: 2021-09
• Study Completion: 2021-09-01
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gluten-free nutrition plan + exercise group	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.
Gluten-free nutrition plan group	Gluten-free nutrition plan group	Women with celiac disease following a gluten-free isocaloric dietary plan.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Alicante; 🇪🇸 Alicante, San Vicente Del Raspeig, Spain