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

Primary Purpose

Celiac Disease, Diet, Gluten-Free, Exercise

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gluten-free nutrition plan + exercise group
Gluten-free nutrition plan group
Active Comparator: Celiac controls group
Sponsored by
University of Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alicante

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Gluten-free nutrition plan + exercise group

Gluten-free nutrition plan group

Celiac controls group

Non-celiac controls group

Arm Description

Celiac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan.

Women with celiac disease following a gluten-free isocaloric dietary plan.

Women with celiac disease in whom all variables are measured but no intervention is performed.

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

Outcomes

Primary Outcome Measures

Quality of Life (QoL)
A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization
Body Composition - Fat Mass
Evaluation of body fat by bioimpedance.
Body Composition - Lean Body Mass
Evaluation of lean body mass by bioimpedance.
Body Composition - Visceral Fat
Evaluation of visceral fat by bioimpedance.
Weight
Weight evaluation using a digital scale
Strength
A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)
Adherence to gluten-free diet
Questionnaire "Adherence to gluten-free diet" was performed.
Anthropometric assessment - Skinfolds
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Perimeters
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Diameters
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Height
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Resistance test
6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.
Balance test
By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports.
Functional autonomy test
GDLAM protocol
State of mind
Evaluation by using the Profile of Mood States POMS questionnaire.
Eating disorders
Eating disorders questionnaire: Eating Attitudes Test Questionnaire (EAT) in its 26-item version (EAT-26) in Spanish (Rivas et al., 2010).
Heart rate variability
Using novel Firstbeat Bodyguard device (Föhr, 2016)
Maximum oxygen consumption
Heart rate measurement and recording with Firsbeat Bodyguard
Glucose in blood
Glucose by blood test
Cholesterol in blood
Cholesterol by blood test
Creatinine in blood
Creatinine by blood test
Urea in blood
Urea by blood test

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
September 10, 2021
Sponsor
University of Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT05052164
Brief Title
Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
Official Title
Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women. Effects Of Gluten-Free Diet And Physical Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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...).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Diet, Gluten-Free, Exercise, Resistance Training, Quality of Life, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gluten-free nutrition plan + exercise group
Arm Type
Experimental
Arm Description
Celiac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan.
Arm Title
Gluten-free nutrition plan group
Arm Type
Experimental
Arm Description
Women with celiac disease following a gluten-free isocaloric dietary plan.
Arm Title
Celiac controls group
Arm Type
Active Comparator
Arm Description
Women with celiac disease in whom all variables are measured but no intervention is performed.
Arm Title
Non-celiac controls group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Gluten-free nutrition plan + exercise group
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Gluten-free nutrition plan group
Intervention Description
Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Celiac controls group
Intervention Description
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 Outcome Measure Information:
Title
Quality of Life (QoL)
Description
A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization
Time Frame
12 weeks
Title
Body Composition - Fat Mass
Description
Evaluation of body fat by bioimpedance.
Time Frame
12 weeks
Title
Body Composition - Lean Body Mass
Description
Evaluation of lean body mass by bioimpedance.
Time Frame
12 weeks
Title
Body Composition - Visceral Fat
Description
Evaluation of visceral fat by bioimpedance.
Time Frame
12 weeks
Title
Weight
Description
Weight evaluation using a digital scale
Time Frame
12 weeks
Title
Strength
Description
A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)
Time Frame
12 weeks
Title
Adherence to gluten-free diet
Description
Questionnaire "Adherence to gluten-free diet" was performed.
Time Frame
12 weeks
Title
Anthropometric assessment - Skinfolds
Description
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time Frame
12 weeks
Title
Anthropometric assessment - Perimeters
Description
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time Frame
12 weeks
Title
Anthropometric assessment - Diameters
Description
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time Frame
12 weeks
Title
Anthropometric assessment - Height
Description
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Time Frame
12 weeks
Title
Resistance test
Description
6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.
Time Frame
12 weeks
Title
Balance test
Description
By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports.
Time Frame
12 weeks
Title
Functional autonomy test
Description
GDLAM protocol
Time Frame
12 weeks
Title
State of mind
Description
Evaluation by using the Profile of Mood States POMS questionnaire.
Time Frame
12 weeks
Title
Eating disorders
Description
Eating disorders questionnaire: Eating Attitudes Test Questionnaire (EAT) in its 26-item version (EAT-26) in Spanish (Rivas et al., 2010).
Time Frame
12 weeks
Title
Heart rate variability
Description
Using novel Firstbeat Bodyguard device (Föhr, 2016)
Time Frame
12 weeks
Title
Maximum oxygen consumption
Description
Heart rate measurement and recording with Firsbeat Bodyguard
Time Frame
12 weeks
Title
Glucose in blood
Description
Glucose by blood test
Time Frame
12 weeks
Title
Cholesterol in blood
Description
Cholesterol by blood test
Time Frame
12 weeks
Title
Creatinine in blood
Description
Creatinine by blood test
Time Frame
12 weeks
Title
Urea in blood
Description
Urea by blood test
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Alicante
City
Alicante
State/Province
San Vicente Del Raspeig
ZIP/Postal Code
03690
Country
Spain

12. IPD Sharing Statement

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

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