Curcumin and Retinal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low curcumin group, High curcumin group.
- Who it may be relevant to
- Registry conditions: Bioavailability, Gut Microbiome, Safety. Basic parameters: 40 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Curcumin and Retinal Amyloid-beta Pilot Study
Overview
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.
Interventions
- Drug Low curcumin group
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks. - Drug High curcumin group
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.
Primary outcome measures
- Retinal imaging- amyloid fluorescent intensity [Time frame: Baseline]
- Retinal imaging-amyloid fluorescent deposit number [Time frame: Baseline]
- Retinal imaging-amyloid fluorescent location [Time frame: Baseline]
- Retinal imaging-amyloid fluorescent intensity [Time frame: After 2 weeks]
- Retinal imaging-amyloid fluorescent deposit number [Time frame: After 2 weeks]
- Retinal imaging-amyloid fluorescent location [Time frame: After 2 weeks]
Secondary outcome measures (12)
- Bioavailability- curcumin concentrations in plasma [Time frame: Baseline]
- Bioavailability-curcumin concentrations in red blood cells [Time frame: Baseline]
- Bioavailability-curcumin concentrations in plasma [Time frame: After 2 weeks]
- Bioavailability-curcumin concentrations in red blood cells [Time frame: After 2 weeks]
- Liver function-serum AST [Time frame: Baseline]
- Liver function-serum ALT [Time frame: Baseline]
- Kidney function-serum BUN [Time frame: Baseline]
- Liver function-serum ALT [Time frame: After 2 weeks]
- Kidney function-serum BUN [Time frame: After 2 weeks]
- Gut microbiome-abundance [Time frame: Baseline]
- Gut microbiome-composition [Time frame: Baseline]
- Gut microbiome-abundance [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Texas Tech University Health Sciences Center — Lubbock
Identifiers
NCT: NCT05774704 · Curcumin-Retinal Pilot Study