Curcumin and Retinal Study

Phase 1

Recruiting

• Conditions: Safety; Gut Microbiome; Bioavailability
• Interventions: Drug: Low curcumin group; Drug: High curcumin group

• Registration Number: NCT05774704
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-20
• Study Start: 2023-08-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low curcumin group	Low curcumin group	-
High curcumin group	High curcumin group	-

Primary Outcome Measures

Name	Time	Method
Retinal imaging- amyloid fluorescent intensity	Baseline	To access amyloid fluorescent intensity
Retinal imaging-amyloid fluorescent deposit number	After 2 weeks	To access amyloid fluorescent deposit number
Retinal imaging-amyloid fluorescent intensity	After 2 weeks	To access amyloid fluorescent intensity
Retinal imaging-amyloid fluorescent location	After 2 weeks	To access amyloid fluorescent location

Secondary Outcome Measures

Name	Time	Method
Bioavailability-curcumin concentrations in red blood cells	After 2 weeks	To measure curcumin concentrations in red blood cells
Liver function-serum AST	Baseline	To assess serum AST
Liver function-serum ALT	After 2 weeks	To assess serum ALT
Bioavailability- curcumin concentrations in plasma	Baseline	To measure curcumin concentrations in plasma
Bioavailability-curcumin concentrations in plasma	After 2 weeks	To measure curcumin concentrations in plasma
Gut microbiome-composition	After 2 weeks	To measure the composition of intestinal bacterial in feces
Kidney function-serum BUN	After 2 weeks	To assess serum BUN
Gut microbiome-abundance	After 2 weeks	To measure the abundance of intestinal bacterial in feces

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States