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

NCT03429231 | Completed

• 1 other identifier: QUbiquinol17
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Health Status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline General Health at 3 months

  Baseline and 3 months

• Change from Baseline Mood at three months

  Baseline and 3 months

• Change from Baseline Cramps at three months

  Baseline and 3 months

Study Arms (2)

Active Group

Women who are taking coenzyme Q and who will continue taking it for 3 months

Dietary Supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol

Control Group

Women who are not taking coenzyme Q and who will not take it in the next 3 months

Interventions

Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol DIETARY_SUPPLEMENT

Patients in the active group will take one tablet a day orally

Active Group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy postmenopausal woman between 45 and 65 years

You may qualify if:

• 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.

Sponsors & Collaborators

• Dr. Santiago Palacios: lead

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 12, 2018
• Study Start: November 23, 2017
• Primary Completion: March 31, 2018
• Study Completion: April 15, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)