Curcumin and Retinal Study

NCT05774704 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Curcumin-Retinal Pilot Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Gut Microbiome; Safety; Bioavailability

Outcome Measures

Primary Outcomes (6)

• Retinal imaging- amyloid fluorescent intensity

  To access amyloid fluorescent intensity

  Baseline

• Retinal imaging-amyloid fluorescent deposit number

  To access amyloid fluorescent deposit number

  Baseline

• Retinal imaging-amyloid fluorescent location

  To access amyloid fluorescent location

  Baseline

• Retinal imaging-amyloid fluorescent intensity

  To access amyloid fluorescent intensity

  After 2 weeks

• Retinal imaging-amyloid fluorescent deposit number

  To access amyloid fluorescent deposit number

  After 2 weeks

• Retinal imaging-amyloid fluorescent location

  To access amyloid fluorescent location

  After 2 weeks

Secondary Outcomes (13)

• Bioavailability- curcumin concentrations in plasma

  Baseline

• Bioavailability-curcumin concentrations in red blood cells

  Baseline

• Bioavailability-curcumin concentrations in plasma

  After 2 weeks

• Bioavailability-curcumin concentrations in red blood cells

  After 2 weeks

• Liver function-serum AST

  Baseline

Study Arms (2)

Low curcumin group

ACTIVE COMPARATOR

Drug: Low curcumin group

High curcumin group

ACTIVE COMPARATOR

Drug: High curcumin group

Interventions

High curcumin group DRUG

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

High curcumin group

Low curcumin group DRUG

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

Low curcumin group

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

Study Officials

• Chwan-Li (Leslie) Shen, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chwan-Li (Leslie) Shen, PhD

CONTACT

8067432815; leslie.shen@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-week double blinded, placebo-controlled, and randomized intervention trial with allocation 1:1 for two treatment arms (low curcumin group and high curcumin group).

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 20, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)