Annatto-derived GG for Statin-associated Myopathy

Conditions

• Myopathy; Primary

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Placebo — DIETARY_SUPPLEMENT
  300 mg olive oil
• Low GG — DIETARY_SUPPLEMENT
  150 mg GG
• High GG — DIETARY_SUPPLEMENT
  300 mg GG

Study Details

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

Key Dates

Start date

Jul 15, 2022

Status verified

Sep 2025

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

95 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner
• Active Comparator: Low GG
  LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner
• Active Comparator: High GG
  HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner

Primary Outcome Measure

SAMS-CI [ Time Frame: change in SAMS-CI at 3 months ]

Central Contacts

• Chwan-Li (Leslie) Shen, PhD
  8067432815
  [email protected]

Locations (1)

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