Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
1 other identifier
interventional
28
1 country
1
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...).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedSeptember 22, 2021
September 1, 2021
2.9 years
September 7, 2021
September 10, 2021
Conditions
Outcome Measures
Primary Outcomes (22)
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
Weight
Weight evaluation using a digital scale
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
Cholesterol in blood
Cholesterol by blood test
12 weeks
Creatinine in blood
Creatinine by blood test
12 weeks
Urea in blood
Urea by blood test
12 weeks
Study Arms (4)
Gluten-free nutrition plan + exercise group
EXPERIMENTALCeliac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan.
Gluten-free nutrition plan group
EXPERIMENTALWomen with celiac disease following a gluten-free isocaloric dietary plan.
Celiac controls group
ACTIVE COMPARATORWomen with celiac disease in whom all variables are measured but no intervention is performed.
Non-celiac controls group
NO INTERVENTIONNon 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Women
- Over 40 years old
- Menopausal or post-menopausal women
- Women with celiac disease (in the case of the experimental groups)
You may not qualify if:
- Men
- Women of childbearing age
- Women \< 40 years old
- Failure to sign informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alicante
Alicante, San Vicente Del Raspeig, 03690, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 22, 2021
Study Start
September 1, 2018
Primary Completion
August 1, 2021
Study Completion
September 1, 2021
Last Updated
September 22, 2021
Record last verified: 2021-09