Recruiting
Phase 1
Phase 2

Curcumin & Retinal

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT05774704

Conditions

Bioavailability

Gut Microbiome

Safety

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Low curcumin group

High curcumin group

Study Details

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.

Conditions

Bioavailability

Gut Microbiome

Safety

Study ID

NCT05774704

Start date

Aug 21, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Low curcumin group

active comparator: High curcumin group

Interventions

Low curcumin group

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

High curcumin group

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Chwan-Li (Leslie) Shen, PhD

8067432815leslie.shen@ttuhsc.edu

Locations

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Chwan-Li (Leslie) Shen, PhD

806-743-2815Leslie.Shen@ttuhsc.edu

Principal Investigator:

Chwan-Li (Leslie) Shen, PhD

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2026-01-13.