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

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

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...).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Celiac Disease; Exercise; Body Composition; Diet, Gluten-Free; Resistance Training
• Intervention / Treatment: Behavioral: Gluten-free nutrition plan + exercise group; Behavioral: Gluten-free nutrition plan group; Behavioral: Active Comparator: Celiac controls group

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • San Vicente Del Raspeig
    • Alicante, San Vicente Del Raspeig, Spain, 03690
      • University of Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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
EXPERIMENTAL: Gluten-free nutrition plan group; Women with celiac disease following a gluten-free isocaloric dietary plan.	Behavioral: Gluten-free nutrition plan group; Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
ACTIVE_COMPARATOR: Celiac controls group; Women with celiac disease in whom all variables are measured but no intervention is performed.	Behavioral: 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
NO_INTERVENTION: Non-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight evaluation using a digital scale	12 weeks
Cholesterol in blood	Cholesterol by blood test	12 weeks
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
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
Creatinine in blood	Creatinine by blood test	12 weeks
Urea in blood	Urea by blood test	12 weeks

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (ACTUAL): September 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: UA-2018-10-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No