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Completed

NCT Number: NCT05052164

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

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...).

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Key information

Conditions

Celiac Disease Behavior Body Composition Diet, Gluten-Free Digestive System Diseases Exercise Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Quality of Life Resistance Training

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alicante

Alicante, San Vicente Del Raspeig, 03690, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free nutrition plan + exercise group

Behavioral

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

Behavioral

Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program

Active Comparator: Celiac controls group

Behavioral

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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