Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Location status: Recruiting
Location contact
Chwan-Li (Leslie) Shen, PhD
CONTACT
Chwan-Li (Leslie) Shen, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05774704
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.
Interested in participating?
Request Info40 year–89 year
All sexes
Interventional
Phase 1 / Phase 2
Lubbock, Texas, 79430, United States
Location status: Recruiting
Chwan-Li (Leslie) Shen, PhD
CONTACT
Chwan-Li (Leslie) Shen, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.
Time frame: Baseline
To access amyloid fluorescent intensity
Time frame: Baseline
To access amyloid fluorescent deposit number
Time frame: Baseline
To access amyloid fluorescent location
Time frame: After 2 weeks
To access amyloid fluorescent intensity
Time frame: After 2 weeks
To access amyloid fluorescent deposit number
Time frame: After 2 weeks
To access amyloid fluorescent location
Time frame: Baseline
To measure curcumin concentrations in plasma
Time frame: Baseline
To measure curcumin concentrations in red blood cells
Time frame: After 2 weeks
To measure curcumin concentrations in plasma
Time frame: After 2 weeks
To measure curcumin concentrations in red blood cells
Time frame: Baseline
To assess serum AST
Time frame: Baseline
To assess serum ALT
Time frame: Baseline
To assess serum BUN
Time frame: After 2 weeks
To assess serum ALT
Time frame: After 2 weeks
To assess serum BUN
Time frame: Baseline
To measure the abundance of intestinal bacterial in feces
Time frame: Baseline
To measure the composition of intestinal bacterial in feces
Time frame: After 2 weeks
To measure the abundance of intestinal bacterial in feces
Time frame: After 2 weeks
To measure the composition of intestinal bacterial in feces
Contact information is provided by the study sponsor or research team.
Texas Tech University Health Sciences Center
Other
Curcumin and Retinal Amyloid-beta Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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