Clinical trial

Curcumin and Retinal Amyloid-beta Pilot Study

Name
Curcumin-Retinal Pilot Study
Description
To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance/composition of gut microbiota.
Trial arms
Trial start
2023-08-21
Estimated PCD
2025-03-31
Trial end
2025-03-31
Status
Recruiting
Phase
Early phase I
Treatment
Low curcumin group
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.
Arms:
Low curcumin group
High curcumin group
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.
Arms:
High curcumin group
Size
60
Primary endpoint
Retinal imaging- amyloid fluorescent intensity
Baseline
Retinal imaging-amyloid fluorescent deposit number
Baseline
Retinal imaging-amyloid fluorescent location
Baseline
Retinal imaging-amyloid fluorescent intensity
After 2 weeks
Retinal imaging-amyloid fluorescent deposit number
After 2 weeks
Retinal imaging-amyloid fluorescent location
After 2 weeks
Eligibility criteria
Inclusion: * Both male and female, age 40 - 89 years. * Diagnosed with Aβ deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aβ deposits in retina within 6 months before the consent session, we will use this diagnosis/documentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study. * No pre-existing liver or kidney diseases by self-report. Exclusion: * Patients with ocular diseases (macular degeneration, severe diabetes retinopathy) * Had used systemic antibiotics within 1 month prior to the start of the study intervention * Had taken any turmeric or curcumin products within 2 weeks prior to the start of the study intervention * Had a known allergy to black pepper * Women that are pregnant or breastfeeding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a 2-week double blinded, placebo-controlled, and randomized intervention trial with allocation 1:1 for two treatment arms (low curcumin group and high curcumin group).', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-08-24

1 organization

2 products

3 indications

Indication
Bioavailability
Indication
Gut Microbiome
Indication
Safety