Curcumin and Retinal Study
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-89
SponsorTexas Tech University Health Sciences Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Patients with ocular diseases (macular degeneration, severe diabetes retinopathy)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Low curcumin group
DrugOne curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.
High curcumin group
DrugOne curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Low curcumin groupActive comparator 1 intervention
Group B: High curcumin groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Retinal imaging- amyloid fluorescent intensity
To access amyloid fluorescent intensity
Time frame
Baseline2
Retinal imaging-amyloid fluorescent deposit number
To access amyloid fluorescent deposit number
Time frame
Baseline3
Retinal imaging-amyloid fluorescent location
To access amyloid fluorescent location
Time frame
Baseline4
Retinal imaging-amyloid fluorescent intensity
To access amyloid fluorescent intensity
Time frame
After 2 weeksSecondary outcomes
1
Bioavailability- curcumin concentrations in plasma
To measure curcumin concentrations in plasma
Time frame
Baseline2
Bioavailability-curcumin concentrations in red blood cells
To measure curcumin concentrations in red blood cells
Time frame
Baseline3
Bioavailability-curcumin concentrations in plasma
To measure curcumin concentrations in plasma
Time frame
After 2 weeks4
Bioavailability-curcumin concentrations in red blood cells
To measure curcumin concentrations in red blood cells
Time frame
After 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov