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NCT Number: NCT05774704

Curcumin and Retinal Study

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.

Recruiting

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Key information

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location status: Recruiting

Location contact

Chwan-Li (Leslie) Shen, PhD

CONTACT

[email protected]

806-743-2815

Chwan-Li (Leslie) Shen, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low curcumin group

Drug

One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.

High curcumin group

Drug

One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.

Primary outcomes

  1. Retinal imaging- amyloid fluorescent intensity

    Time frame: Baseline

    To access amyloid fluorescent intensity

  2. Retinal imaging-amyloid fluorescent deposit number

    Time frame: Baseline

    To access amyloid fluorescent deposit number

  3. Retinal imaging-amyloid fluorescent location

    Time frame: Baseline

    To access amyloid fluorescent location

  4. Retinal imaging-amyloid fluorescent intensity

    Time frame: After 2 weeks

    To access amyloid fluorescent intensity

  5. Retinal imaging-amyloid fluorescent deposit number

    Time frame: After 2 weeks

    To access amyloid fluorescent deposit number

  6. Retinal imaging-amyloid fluorescent location

    Time frame: After 2 weeks

    To access amyloid fluorescent location

Secondary outcomes

  1. Bioavailability- curcumin concentrations in plasma

    Time frame: Baseline

    To measure curcumin concentrations in plasma

  2. Bioavailability-curcumin concentrations in red blood cells

    Time frame: Baseline

    To measure curcumin concentrations in red blood cells

  3. Bioavailability-curcumin concentrations in plasma

    Time frame: After 2 weeks

    To measure curcumin concentrations in plasma

  4. Bioavailability-curcumin concentrations in red blood cells

    Time frame: After 2 weeks

    To measure curcumin concentrations in red blood cells

  5. Liver function-serum AST

    Time frame: Baseline

    To assess serum AST

  6. Liver function-serum ALT

    Time frame: Baseline

    To assess serum ALT

  7. Kidney function-serum BUN

    Time frame: Baseline

    To assess serum BUN

  8. Liver function-serum ALT

    Time frame: After 2 weeks

    To assess serum ALT

  9. Kidney function-serum BUN

    Time frame: After 2 weeks

    To assess serum BUN

  10. Gut microbiome-abundance

    Time frame: Baseline

    To measure the abundance of intestinal bacterial in feces

  11. Gut microbiome-composition

    Time frame: Baseline

    To measure the composition of intestinal bacterial in feces

  12. Gut microbiome-abundance

    Time frame: After 2 weeks

    To measure the abundance of intestinal bacterial in feces

  13. Gut microbiome-composition

    Time frame: After 2 weeks

    To measure the composition of intestinal bacterial in feces

Study contacts

Contact information is provided by the study sponsor or research team.

Chwan-Li (Leslie) Shen, PhD

CONTACT

[email protected]

8067432815

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Curcumin and Retinal Amyloid-beta Pilot Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
Jan 13, 2026

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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