Celiac DiseaseNCT05052164
Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
A study testing Gluten-free nutrition plan + exercise group and Gluten-free nutrition plan group in people with Celiac Disease and Diet, Gluten-Free, run by University of Alicante at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Diet, Gluten-Free, Exercise
- What is being tested?
- Gluten-free nutrition plan + exercise group and Gluten-free nutrition plan group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Over 40 years old
- Menopausal or post-menopausal women
- Women with celiac disease (in the case of the experimental groups)
Who cannot join
- Men
- Women of childbearing age
- Women < 40 years old
- Failure to sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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...).
- Conditions
- Celiac Disease, Diet, Gluten-Free, Exercise, Resistance Training, Quality of Life, Body Composition
- Being tested
- Gluten-free nutrition plan + exercise group, Gluten-free nutrition plan group, Active Comparator: Celiac controls group
- Medical subject headings
- Celiac Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free nutrition plan + exercise groupBehavioural
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 groupBehavioural
Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
Active Comparator: Celiac controls groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Gluten-free nutrition plan + exercise group | Experimental | Celiac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan. Receives: Behavioral: Gluten-free nutrition plan + exercise group |
| Gluten-free nutrition plan group | Experimental | Women with celiac disease following a gluten-free isocaloric dietary plan. Receives: Behavioral: Gluten-free nutrition plan group |
| Celiac controls group | Active comparator | Women with celiac disease in whom all variables are measured but no intervention is performed. Receives: Behavioral: Active Comparator: Celiac controls group |
| Non-celiac controls group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL)
A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization
Measured: 12 weeks
Body Composition - Fat Mass
Evaluation of body fat by bioimpedance.
Measured: 12 weeks
Body Composition - Lean Body Mass
Evaluation of lean body mass by bioimpedance.
Measured: 12 weeks
Body Composition - Visceral Fat
Evaluation of visceral fat by bioimpedance.
Measured: 12 weeks
Weight
Weight evaluation using a digital scale
Measured: 12 weeks
Strength
A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)
Measured: 12 weeks
Adherence to gluten-free diet
Questionnaire "Adherence to gluten-free diet" was performed.
Measured: 12 weeks
Anthropometric assessment - Skinfolds
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Measured: 12 weeks
Anthropometric assessment - Perimeters
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Measured: 12 weeks
Anthropometric assessment - Diameters
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Measured: 12 weeks
Anthropometric assessment - Height
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Measured: 12 weeks
Resistance test
6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.
Measured: 12 weeks
Balance test
By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports.
Measured: 12 weeks
Functional autonomy test
GDLAM protocol
Measured: 12 weeks
State of mind
Evaluation by using the Profile of Mood States POMS questionnaire.
Measured: 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).
Measured: 12 weeks
Heart rate variability
Using novel Firstbeat Bodyguard device (Föhr, 2016)
Measured: 12 weeks
Maximum oxygen consumption
Heart rate measurement and recording with Firsbeat Bodyguard
Measured: 12 weeks
Glucose in blood
Glucose by blood test
Measured: 12 weeks
Cholesterol in blood
Cholesterol by blood test
Measured: 12 weeks
Creatinine in blood
Creatinine by blood test
Measured: 12 weeks
Urea in blood
Urea by blood test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Sep 2018
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052164
- Sponsor's protocol ID
- UA-2018-10-22
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women. Effects Of Gluten-Free Diet And Physical Exercise
- ClinicalTrials.gov ID
- NCT05052164
- Acronym / sponsor ID
- UA-2018-10-22
- Conditions
- Celiac Disease, Diet, Gluten-Free, Exercise, Resistance Training, Quality of Life, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gluten-free nutrition plan + exercise group | Experimental | Behavioral: Gluten-free nutrition plan + exercise groupCeliac women who perform a physical exercise program 3/4 times per week and a gluten-free isocaloric dietary plan. |
| Gluten-free nutrition plan group | Experimental | Behavioral: Gluten-free nutrition plan groupWomen with celiac disease following a gluten-free isocaloric dietary plan. |
| Celiac controls group | Active comparator | Behavioral: Active Comparator: Celiac controls groupWomen with celiac disease in whom all variables are measured but no intervention is performed. |
| Non-celiac controls group | No intervention | –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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Over 40 years old
- Menopausal or post-menopausal women
- Women with celiac disease (in the case of the experimental groups)
Key exclusion criteria (4 listed)
- Men
- Women of childbearing age
- Women < 40 years old
- Failure to sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten-free nutrition plan + exercise groupMenopausal 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 | Behavioural | Gluten-free nutrition plan + exercise group |
| Gluten-free nutrition plan groupMenopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program | Behavioural | Gluten-free nutrition plan group |
| Active Comparator: Celiac controls groupMenopausal 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 | Behavioural | Celiac controls group |
Primary outcome
Quality of Life (QoL)
Time frame: 12 weeks
A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization
Body Composition - Fat Mass
Time frame: 12 weeks
Evaluation of body fat by bioimpedance.
Body Composition - Lean Body Mass
Time frame: 12 weeks
Evaluation of lean body mass by bioimpedance.
Body Composition - Visceral Fat
Time frame: 12 weeks
Evaluation of visceral fat by bioimpedance.
Weight
Time frame: 12 weeks
Weight evaluation using a digital scale
Strength
Time frame: 12 weeks
A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)
Adherence to gluten-free diet
Time frame: 12 weeks
Questionnaire "Adherence to gluten-free diet" was performed.
Anthropometric assessment - Skinfolds
Time frame: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Perimeters
Time frame: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Diameters
Time frame: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Height
Time frame: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Resistance test
Time frame: 12 weeks
6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.
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.
Functional autonomy test
Time frame: 12 weeks
GDLAM protocol
State of mind
Time frame: 12 weeks
Evaluation by using the Profile of Mood States POMS questionnaire.
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).
Heart rate variability
Time frame: 12 weeks
Using novel Firstbeat Bodyguard device (Föhr, 2016)
Maximum oxygen consumption
Time frame: 12 weeks
Heart rate measurement and recording with Firsbeat Bodyguard
Glucose in blood
Time frame: 12 weeks
Glucose by blood test
Cholesterol in blood
Time frame: 12 weeks
Cholesterol by blood test
Creatinine in blood
Time frame: 12 weeks
Creatinine by blood test
Urea in blood
Time frame: 12 weeks
Urea by blood test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free nutrition plan + exercise group and Gluten-free nutrition plan group in people with Celiac Disease and Diet, Gluten-Free, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: 12 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.