← Back to Search

Dietary Supplement

Annatto-derived GG for Statin-associated Myopathy (GG-statin Trial)

Phase 1 & 2
Recruiting
Led By Chwan-Li (Leslie) Shen, PhD
Research Sponsored by Texas Tech University Health Sciences Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients currently receiving a statin who developed new-onset myalgias within 90 days of initiation or a dosage increase
Age ≥40 of either sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in bpi at 3 months
Awards & highlights

GG-statin Trial Summary

This trial looks at whether taking a supplement derived from the annatto plant can improve muscle health for people taking statins.

Who is the study for?
This trial is for people over 40 who started having muscle pain after beginning or increasing the dosage of statin medication. It's not for pregnant or breastfeeding women, those with genetic muscle metabolism disorders, recent steroid or CoQ10 supplement use, cancer patients, or individuals with major neurological or psychiatric issues.Check my eligibility
What is being tested?
The study tests if a supplement called annatto-derived geranylgeraniol (GG) can help with muscle pain caused by statins. Participants will receive either a placebo, low dose GG, or high dose GG for three months to see which helps more.See study design
What are the potential side effects?
While specific side effects are not listed here, supplements like GG could potentially cause digestive upset, allergic reactions, headaches, and may interact with other medications.

GG-statin Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are taking a statin and recently started having muscle pain within the last 90 days.
Select...
You must be at least 40 years old, regardless of whether you are male or female.
Select...
You are taking statin medication and experiencing muscle pain with or without other symptoms.

GG-statin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes in serum atrogin 1 at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in serum atrogin 1 at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BPI
SAMS-CI
Secondary outcome measures
Functional lower body strength
Heel raise test
Lower body isometric strength
+8 more

GG-statin Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Low GGActive Control1 Intervention
LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner
Group II: High GGActive Control1 Intervention
HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner
Group III: PlaceboPlacebo Group1 Intervention
Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor
103 Previous Clinical Trials
10,549 Total Patients Enrolled
Chwan-Li (Leslie) Shen, PhDPrincipal InvestigatorTexas Tech Health Science Center
2 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

High GG (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05312424 — Phase 1 & 2
Myopathy Research Study Groups: Placebo, Low GG, High GG
Myopathy Clinical Trial 2023: High GG Highlights & Side Effects. Trial Name: NCT05312424 — Phase 1 & 2
High GG (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312424 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the anticipated results from this clinical experiment?

"This trial is aiming to observe a change in SAMS-CI at the three month mark. Secondary measurements include an analysis of blood lipids, lower body isometric strength with dynamometer readings and functional lower body strength assessed using a 50m walk loaded with weight."

Answered by AI

Are there any open slots for enrollment in this clinical experiment?

"Clinicaltrials.gov states that this medical study, first posted on July 15th 2022 and last updated on May 10th 2022, is not currently looking for patients to join the trial. Nevertheless, there are still 30 other trials which remain open to enrollment."

Answered by AI
~36 spots leftby Mar 2025