Recruiting

LPC-DHA vs. TAG-DHA

Sponsor:

University of Cincinnati

Code:

NCT06933095

Conditions

Eldery People

Cognitive Decline

Memory Decline

DHA CNS Delivery

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

Study Details

Brief summary:

The purpose of this placebo-controlled trial is to compare the effects of 24-weeks supplementation with LPC-DHA and TAG-DHA on cerebrospinal fluid and blood DHA levels, as well as biomarkers of central neurodegenerative and neurotrophic activity, in elderly adults experiencing early signs of cognitive/memory decline including those with mild cognitive impairment (MCI). Extant evidence supports our overarching hypothesis that LPC-DHA supplementation will be more effective than TAG-DHA for increasing central (CSF) DHA levels and improving biomarker profiles in elderly adults. To assess this hypothesis, the following aims are proposed:

SPECIFIC AIM 1: To compare the effects of LPC-DHA and TAG-DHA supplementation on peripheral and CSF DHA levels in elderly adults experiencing early signs of cognitive/memory decline.

SPECIFIC AIM 2: To compare the effects of LPC-DHA and TAG-DHA supplementation on neurotrophic and neurodegenerative biomarkers.

Secondary Aim: To investigate whether changes in CSF DHA levels correlate with changes in objective measures of executive functioning and episodic memory performance.

Conditions

Eldery People

Cognitive Decline

Memory Decline

DHA CNS Delivery

Study ID

NCT06933095

Start date

Sep 15, 2024

Status verified date

Aug, 2026

Completion date

Sep 15, 2029

Anticipated

Primary completion date

Sep 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. men and women 55 to 82 years old;
2. presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR;
3. No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
4. fluency in English;
5. ability to comprehend and comply with the research protocol; and
6. provision of written informed consent.

Exclusion Criteria:

1. diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, head trauma with loss of consciousness lasting more than 5 minutes and resulting in persisting functional decline within the three years prior to enrollment, epilepsy, leukoencephalopathy, other neurological conditions that would interfere the study objectives, mMIST <8 or MoCA-MI score <7;
2. self-reported history of any psychotic disorder or bipolar disorder;
3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;
4. allergy to shellfish or seafood;
5. current substance use causing physiological dependence or persisting change in functional capability;
6. concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications;
7. weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.

Study Design

Enrollment

153 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo (mixture of olive oil, corn oil, palm oil)

Placebo

active comparator: fish oil

Fish Oil

experimental: LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t

LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

Interventions

LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

Primary outcome measure

  • CSF Docosahexaenoic acid (DHA) levels [ Time Frame: From baseline through week 24 ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-08-19.