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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes in serum il-6 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 Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in lower body isometric strength at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in lower body isometric strength 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: 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 II: 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 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

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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
104 Previous Clinical Trials
10,679 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: High GG, Placebo, Low 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
~34 spots leftby Jun 2025
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