Observational Study to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol

Study Overview
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Brief Summary
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Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it

Detailed Description
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Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it

Official Title
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Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol

Conditions
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Health Status

Intervention / Treatment
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* Dietary Supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal woman between 45 and 65 years old Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months Exclusión Criteria: Patients with severe mental illness. Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection Any other consideration or finding that, in the opinion of the investigator, considers the non-participation of the subject in the study.

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Group<br>Women who are taking coenzyme Q and who will continue taking it for 3 months | Dietary Supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol<br>* Patients in the active group will take one tablet a day orally<br>|
| Control Group<br>Women who are not taking coenzyme Q and who will not take it in the next 3 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Quality of Life at 3 months | To evaluate the quality of life in healthy postmenopausal women who are taking Coenzyme Q-Ubiquinol for 3 months in comparison with another group that does not take them. The Cervantes Health-Related Quality of Life scale for menopause will be used for this outcome. In that scale next to the 0 and the 5 there are words that describe two opposite answers to the question. Between the 0 and the 5 there are also four boxes numbered 1 to 4. The participants should answer the questions by checking the box that best represents what they think and feel. In other words, they should check 5 if they are completely agree and 0 they are completely disagree. If they are not completely agree or disagree, they should check the boxes in between | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline General Health at 3 months | Health Scale Euroqol EQ-5D will be used for this outcome | Baseline and 3 months | 
| Change from Baseline Mood at three months | An analogic scale will be used for this outcome in wich 0 points is the best mood and 10 points is worst mood | Baseline and 3 months | 
| Change from Baseline Cramps at three months | To assess changes in cramps in patients who had them, a general questionnaire about Cramps will be used to assess mainly the intensity and frequency of crambs. Regarding the intensity 0 is the lower pain and 10 is the worst pain | Baseline and 3 months |