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

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ClinicalTrials.gov Identifier: NCT05052164
Recruitment Status : Completed
First Posted : September 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Alejandro Martínez-Rodríguez, 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...).

Condition or disease Intervention/treatment Phase
Celiac Disease Diet, Gluten-Free Exercise Resistance Training Quality of Life Body Composition Behavioral: Gluten-free nutrition plan + exercise group Behavioral: Gluten-free nutrition plan group Behavioral: Active Comparator: Celiac controls group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women. Effects Of Gluten-Free Diet And Physical Exercise
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : August 1, 2021
Actual Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Quality of Life (QoL) [ Time Frame: 12 weeks ]
    A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization

  2. Body Composition - Fat Mass [ Time Frame: 12 weeks ]
    Evaluation of body fat by bioimpedance.

  3. Body Composition - Lean Body Mass [ Time Frame: 12 weeks ]
    Evaluation of lean body mass by bioimpedance.

  4. Body Composition - Visceral Fat [ Time Frame: 12 weeks ]
    Evaluation of visceral fat by bioimpedance.

  5. Weight [ Time Frame: 12 weeks ]
    Weight evaluation using a digital scale

  6. Strength [ Time Frame: 12 weeks ]
    A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)

  7. Adherence to gluten-free diet [ Time Frame: 12 weeks ]
    Questionnaire "Adherence to gluten-free diet" was performed.

  8. Anthropometric assessment - Skinfolds [ Time Frame: 12 weeks ]
    Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.

  9. Anthropometric assessment - Perimeters [ Time Frame: 12 weeks ]
    Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.

  10. Anthropometric assessment - Diameters [ Time Frame: 12 weeks ]
    Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.

  11. Anthropometric assessment - Height [ Time Frame: 12 weeks ]
    Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.

  12. Resistance test [ Time Frame: 12 weeks ]
    6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.

  13. Balance test [ Time Frame: 12 weeks ]
    By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports.

  14. Functional autonomy test [ Time Frame: 12 weeks ]
    GDLAM protocol

  15. State of mind [ Time Frame: 12 weeks ]
    Evaluation by using the Profile of Mood States POMS questionnaire.

  16. Eating disorders [ Time Frame: 12 weeks ]
    Eating disorders questionnaire: Eating Attitudes Test Questionnaire (EAT) in its 26-item version (EAT-26) in Spanish (Rivas et al., 2010).

  17. Heart rate variability [ Time Frame: 12 weeks ]
    Using novel Firstbeat Bodyguard device (Föhr, 2016)

  18. Maximum oxygen consumption [ Time Frame: 12 weeks ]
    Heart rate measurement and recording with Firsbeat Bodyguard

  19. Glucose in blood [ Time Frame: 12 weeks ]
    Glucose by blood test

  20. Cholesterol in blood [ Time Frame: 12 weeks ]
    Cholesterol by blood test

  21. Creatinine in blood [ Time Frame: 12 weeks ]
    Creatinine by blood test

  22. Urea in blood [ Time Frame: 12 weeks ]
    Urea by blood test



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052164


Locations
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Spain
University of Alicante
Alicante, San Vicente Del Raspeig, Spain, 03690
Sponsors and Collaborators
University of Alicante
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Responsible Party: Prof. Dr. Alejandro Martínez-Rodríguez, Assistant Professor, University of Alicante
ClinicalTrials.gov Identifier: NCT05052164    
Other Study ID Numbers: UA-2018-10-22
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases