RECRUITING

Annatto-derived GG for Statin-associated Myopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.

Official Title

Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy

Quick Facts

Study Start:2022-07-15

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05312424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥40 of either sex * Statin-treated patients with muscle pain alone or accompanied by other symptoms. * Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase	* Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse. * Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions. * Had CoQ10 supplement one month before starting the study. * Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism * Had steroid medication one month before starting the study.

Inclusion Criteria

Exclusion Criteria

* Age ≥40 of either sex
* Statin-treated patients with muscle pain alone or accompanied by other symptoms.
* Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase

* Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.
* Had CoQ10 supplement one month before starting the study.
* Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism
* Had steroid medication one month before starting the study.

Contacts and Locations

Study Contact

Chwan-Li (Leslie) Shen, PhD

CONTACT

8067432815

leslie.shen@ttuhsc.edu

Principal Investigator

Chwan-Li (Leslie) Shen, PhD

PRINCIPAL_INVESTIGATOR

Texas Tech Health Science Center

Study Locations (Sites)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430

United States

Collaborators and Investigators

Sponsor: Texas Tech University Health Sciences Center

Chwan-Li (Leslie) Shen, PhD, PRINCIPAL_INVESTIGATOR, Texas Tech Health Science Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-15

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-07-15

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Myopathy; Primary