Annatto-derived GG for Statin-associated Myopathy

NCT ID: NCT05312424

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10 supplementation has been widely used to reduce statin-related muscle complaints. Several human studies have been reported with inconsistent effects of CoQ10 on statin-related symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol (GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or a high GG dose group. The outcome measures will be assessed at baseline and after 3 months. Muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. We will monitor the safety of subjects after 3 months. Food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. All data will be analyzed statistically.

Conditions

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Myopathy; Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

300 mg olive oil

Low GG

LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner

Group Type ACTIVE_COMPARATOR

Low GG

Intervention Type DIETARY_SUPPLEMENT

150 mg GG

High GG

HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner

Group Type ACTIVE_COMPARATOR

High GG

Intervention Type DIETARY_SUPPLEMENT

300 mg GG

Interventions

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Placebo

300 mg olive oil

Intervention Type DIETARY_SUPPLEMENT

Low GG

150 mg GG

Intervention Type DIETARY_SUPPLEMENT

High GG

300 mg GG

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Tech University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chwan-Li (Leslie) Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech Health Science Center

Locations

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Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chwan-Li (Leslie) Shen, PhD

Role: CONTACT

8067432815

Facility Contacts

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Chwan-Li (Leslie) Shen, PhD

Role: primary

806-743-2815

Other Identifiers

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L22-130

Identifier Type: -

Identifier Source: org_study_id

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