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

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

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

Study Overview

• Status: Completed
• Conditions: Health Status
• Intervention / Treatment: Dietary supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Instituto Palacios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Healthy postmenopausal woman between 45 and 65 years

Description

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active Group; Women who are taking coenzyme Q and who will continue taking it for 3 months	Dietary supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol; Patients in the active group will take one tablet a day orally
Control Group; Women who are not taking coenzyme Q and who will not take it in the next 3 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Santiago Palacios

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): April 15, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: QUbiquinol17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No