BioavailabilityPhase 1/2NCT05774704
Curcumin and Retinal Study
A Phase 1/2 study testing Low curcumin group and High curcumin group in people with Bioavailability and Gut Microbiome, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Gut Microbiome, Safety
- What is being tested?
- Low curcumin group and High curcumin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Chwan-Li (Leslie) Shen, PhD, 806-743-2815, Leslie.Shen@ttuhsc.edu
Chwan-Li (Leslie) Shen, PhD
About this study
Official title: Curcumin and Retinal Amyloid-beta Pilot 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.
Read the detailed description
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.
- Conditions
- Bioavailability, Gut Microbiome, Safety
- Being tested
- Low curcumin group, High curcumin group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low curcumin groupDrug
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.
High curcumin groupDrug
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low curcumin group | Active comparator | Not described Receives: Drug: Low curcumin group |
| High curcumin group | Active comparator | Not described Receives: Drug: High curcumin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal imaging- amyloid fluorescent intensity
To access amyloid fluorescent intensity
Measured: Baseline
Retinal imaging-amyloid fluorescent deposit number
To access amyloid fluorescent deposit number
Measured: Baseline
Retinal imaging-amyloid fluorescent location
To access amyloid fluorescent location
Measured: Baseline
Retinal imaging-amyloid fluorescent intensity
To access amyloid fluorescent intensity
Measured: After 2 weeks
Retinal imaging-amyloid fluorescent deposit number
To access amyloid fluorescent deposit number
Measured: After 2 weeks
Retinal imaging-amyloid fluorescent location
To access amyloid fluorescent location
Measured: After 2 weeks
Secondary outcomes (13)
Bioavailability- curcumin concentrations in plasma
To measure curcumin concentrations in plasma
Measured: Baseline
Bioavailability-curcumin concentrations in red blood cells
To measure curcumin concentrations in red blood cells
Measured: Baseline
Bioavailability-curcumin concentrations in plasma
To measure curcumin concentrations in plasma
Measured: After 2 weeks
Bioavailability-curcumin concentrations in red blood cells
To measure curcumin concentrations in red blood cells
Measured: After 2 weeks
Liver function-serum AST
To assess serum AST
Measured: Baseline
Liver function-serum ALT
To assess serum ALT
Measured: Baseline
Kidney function-serum BUN
To assess serum BUN
Measured: Baseline
Liver function-serum ALT
To assess serum ALT
Measured: After 2 weeks
Kidney function-serum BUN
To assess serum BUN
Measured: After 2 weeks
Gut microbiome-abundance
To measure the abundance of intestinal bacterial in feces
Measured: Baseline
Gut microbiome-composition
To measure the composition of intestinal bacterial in feces
Measured: Baseline
Gut microbiome-abundance
To measure the abundance of intestinal bacterial in feces
Measured: After 2 weeks
Gut microbiome-composition
To measure the composition of intestinal bacterial in feces
Measured: After 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start21 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chwan-Li (Leslie) Shen, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774704
- Sponsor's protocol ID
- Curcumin-Retinal Pilot Study
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin and Retinal Amyloid-beta Pilot Study
- ClinicalTrials.gov ID
- NCT05774704
- Acronym / sponsor ID
- Curcumin-Retinal Pilot Study
- Conditions
- Bioavailability, Gut Microbiome, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low curcumin group | Active comparator | Drug: Low curcumin group |
| High curcumin group | Active comparator | Drug: High curcumin group |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low curcumin groupOne curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks. | Drug | Low curcumin group |
| High curcumin groupOne curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks. | Drug | High curcumin group |
Primary outcome
Retinal imaging- amyloid fluorescent intensity
Time frame: Baseline
To access amyloid fluorescent intensity
Retinal imaging-amyloid fluorescent deposit number
Time frame: Baseline
To access amyloid fluorescent deposit number
Retinal imaging-amyloid fluorescent location
Time frame: Baseline
To access amyloid fluorescent location
Retinal imaging-amyloid fluorescent intensity
Time frame: After 2 weeks
To access amyloid fluorescent intensity
Retinal imaging-amyloid fluorescent deposit number
Time frame: After 2 weeks
To access amyloid fluorescent deposit number
Retinal imaging-amyloid fluorescent location
Time frame: After 2 weeks
To access amyloid fluorescent location
13 secondary outcomes
Bioavailability- curcumin concentrations in plasma
Time frame: Baseline
Bioavailability-curcumin concentrations in red blood cells
Time frame: Baseline
Bioavailability-curcumin concentrations in plasma
Time frame: After 2 weeks
Bioavailability-curcumin concentrations in red blood cells
Time frame: After 2 weeks
Liver function-serum AST
Time frame: Baseline
Liver function-serum ALT
Time frame: Baseline
Kidney function-serum BUN
Time frame: Baseline
Liver function-serum ALT
Time frame: After 2 weeks
Kidney function-serum BUN
Time frame: After 2 weeks
Gut microbiome-abundance
Time frame: Baseline
Gut microbiome-composition
Time frame: Baseline
Gut microbiome-abundance
Time frame: After 2 weeks
Gut microbiome-composition
Time frame: After 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chwan-Li (Leslie) Shen, PhD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low curcumin group and High curcumin group in people with Bioavailability and Gut Microbiome, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chwan-Li (Leslie) Shen, PhD (8067432815, leslie.shen@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal imaging- amyloid fluorescent intensity (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.