Clinical trial NCT05774704: Curcumin and Retinal Study
Official title: Curcumin and Retinal Amyloid-beta Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Bioavailability
Gut Microbiome
Safety
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

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

Primary outcomes:
measure: Retinal imaging- amyloid fluorescent intensity
timeFrame: Baseline
measure: Retinal imaging-amyloid fluorescent deposit number
timeFrame: Baseline
measure: Retinal imaging-amyloid fluorescent location
timeFrame: Baseline
measure: Retinal imaging-amyloid fluorescent intensity
timeFrame: After 2 weeks
measure: Retinal imaging-amyloid fluorescent deposit number
timeFrame: After 2 weeks
measure: Retinal imaging-amyloid fluorescent location
timeFrame: After 2 weeks
Secondary outcomes:
measure: Bioavailability- curcumin concentrations in plasma
timeFrame: Baseline
measure: Bioavailability-curcumin concentrations in red blood cells
timeFrame: Baseline
measure: Bioavailability-curcumin concentrations in plasma
timeFrame: After 2 weeks
measure: Bioavailability-curcumin concentrations in red blood cells
timeFrame: After 2 weeks
measure: Liver function-serum AST
timeFrame: Baseline
measure: Liver function-serum ALT
timeFrame: Baseline
measure: Kidney function-serum BUN
timeFrame: Baseline
measure: Liver function-serum ALT
timeFrame: After 2 weeks
measure: Kidney function-serum BUN
timeFrame: After 2 weeks
measure: Gut microbiome-abundance
timeFrame: Baseline
measure: Gut microbiome-composition
timeFrame: Baseline
measure: Gut microbiome-abundance
timeFrame: After 2 weeks
measure: Gut microbiome-composition
timeFrame: After 2 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Chwan-Li (Leslie) Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: