Curcumin and Retinal Study

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Alzheimer's disease (AD) leads to progressive cognitive decline. Increased amyloid beta (Aβ) burden and Aβ deposits have been shown in the AD retina. Aβ accumulation inside retinal pericytes in AD and pericyte degeneration in the retina mirror prominent features of brain AD pathology. Curcumin, a derivative of turmeric, has a high affinity for amyloid beta. Thus, curcumin would bind to amyloid beta plaques and emit a strong fluorescent signal, suggesting it can be a powerful diagnostic tool for AD. Emerging evidence has shown the connection between the brain and GI tract (gut microbiome), and its potential implications for both metabolic and neurologic diseases including AD. This pilot study is to test how two weeks of curcumin supplementation would cross the blood brain barrier and attach to amyloid beta proteins and to explore the resulting abundance/composition of gut microbiota. The investigators plan to recruit subjects through direct person-to-person solicitation in the Ophthalmology clinics, health fairs, community events, flyers, non-solicited email system, campus announcements, Clinical Research Institute Volunteer Database website, local radio, newspapers, senior newsletters, and TV scripts. The Clinical Research Institute Volunteer database will also be queried and potential subjects contacted as requested in their form. The investigators plan to enroll approximately 100-150 patients to obtain 30-40 qualified subjects at the start of the study. After screening, qualified participants will be randomly assigned to a low curcumin group or high curcumin group. Thus, this pilot study would focus on characterizing the distribution, manifestation, and prevalence of curcumin-loaded retinal Aβ deposits in study subjects with existing Aβ plaque (primary outcome). In addition, this study will assess safety, bioavailability, and fecal microbiome composition (secondary outcome). All outcomes will be assessed at baseline and after 2 weeks of intervention. Data will be analyzed statistically.

Conditions

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Bioavailability Gut Microbiome Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low curcumin group

Group Type ACTIVE_COMPARATOR

Low curcumin group

Intervention Type DRUG

One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.

High curcumin group

Group Type ACTIVE_COMPARATOR

High curcumin group

Intervention Type DRUG

One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.

Interventions

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Low curcumin group

One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.

Intervention Type DRUG

High curcumin group

One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes