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

Health Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429231
• Other study ID #: QUbiquinol17
• Status: Completed
• Start date: November 23, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: May 2018
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2018
• Est. primary completion date: March 31, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Status

Intervention

Dietary Supplement:
• Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol
Patients in the active group will take one tablet a day orally

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Santiago Palacios

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline General Health at 3 months	Health Scale Euroqol EQ-5D will be used for this outcome	Baseline and 3 months
Secondary	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
Secondary	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