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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052164
• Other study ID #: UA-2018-10-22
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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