Curcumin and Retinal Study

Safety Clinical Trial

Official title:

Curcumin and Retinal Amyloid-beta Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774704
• Other study ID #: Curcumin-Retinal Pilot Study
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 21, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Texas Tech University Health Sciences Center
• Contact: Chwan-Li (Leslie) Shen, PhD
• Phone: 8067432815
• Email: leslie.shen[@]ttuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

Inclusion:

• Both male and female, age 40 - 89 years.

• Diagnosed with Aß deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aß 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

Related Conditions & MeSH terms

• Bioavailability
• Gut Microbiome
• Safety

Intervention

Drug:
• Low curcumin group
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.
• High curcumin group
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal imaging- amyloid fluorescent intensity	To access amyloid fluorescent intensity	Baseline
Primary	Retinal imaging-amyloid fluorescent deposit number	To access amyloid fluorescent deposit number	Baseline
Primary	Retinal imaging-amyloid fluorescent location	To access amyloid fluorescent location	Baseline
Primary	Retinal imaging-amyloid fluorescent intensity	To access amyloid fluorescent intensity	After 2 weeks
Primary	Retinal imaging-amyloid fluorescent deposit number	To access amyloid fluorescent deposit number	After 2 weeks
Primary	Retinal imaging-amyloid fluorescent location	To access amyloid fluorescent location	After 2 weeks
Secondary	Bioavailability- curcumin concentrations in plasma	To measure curcumin concentrations in plasma	Baseline
Secondary	Bioavailability-curcumin concentrations in red blood cells	To measure curcumin concentrations in red blood cells	Baseline
Secondary	Bioavailability-curcumin concentrations in plasma	To measure curcumin concentrations in plasma	After 2 weeks
Secondary	Bioavailability-curcumin concentrations in red blood cells	To measure curcumin concentrations in red blood cells	After 2 weeks
Secondary	Liver function-serum AST	To assess serum AST	Baseline
Secondary	Liver function-serum ALT	To assess serum ALT	Baseline
Secondary	Kidney function-serum BUN	To assess serum BUN	Baseline
Secondary	Liver function-serum ALT	To assess serum ALT	After 2 weeks
Secondary	Kidney function-serum BUN	To assess serum BUN	After 2 weeks
Secondary	Gut microbiome-abundance	To measure the abundance of intestinal bacterial in feces	Baseline
Secondary	Gut microbiome-composition	To measure the composition of intestinal bacterial in feces	Baseline
Secondary	Gut microbiome-abundance	To measure the abundance of intestinal bacterial in feces	After 2 weeks
Secondary	Gut microbiome-composition	To measure the composition of intestinal bacterial in feces	After 2 weeks