Trial Outcomes & Findings for Triglyceride Effects on Blood Flow in the Human Brain (NCT NCT05218018)

NCT ID: NCT05218018

Last Updated: 2023-02-08

Results Overview

Change from Baseline in Cerebral Blood Flow Global at 2 Hours

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Value at 2 hours minus value at baseline
• Results posted on: 2023-02-08

Participant Flow

Participant milestones

Measure	Intervention Only one arm of study Lipid drink: 100 mls of heavy cream
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Triglyceride Effects on Blood Flow in the Human Brain

Baseline characteristics by cohort

Measure	Intervention n=30 Participants Only one arm of study Lipid drink: 100 mls of heavy cream
Age, Continuous Age (years)	66.6 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Systolic Blood Pressure	125 mm Hg STANDARD_DEVIATION 19 • n=5 Participants
Diastolic Blood Pressure	74 mm Hg STANDARD_DEVIATION 7 • n=5 Participants
Body Mass Index (BMI)	26.1 kg/meter squared STANDARD_DEVIATION 4.2 • n=5 Participants
Apolipoprotein E4 (APOE4) carrier status E4 Carrier	14 Participants n=5 Participants
Apolipoprotein E4 (APOE4) carrier status E4 Non Carrier	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Value at 2 hours minus value at baseline

Population: One participant's MRI data had to be excluded as the baseline data did not pass quality control metrics

Change from Baseline in Cerebral Blood Flow Global at 2 Hours

Outcome measures

Measure	Intervention n=29 Participants Only one arm of study Lipid drink: 100 mls of heavy cream
Cerebral Blood Flow Global	-2.2 ml/100g/min Standard Deviation 3.5

PRIMARY outcome

Timeframe: 1 hour minus baseline, 2 hours minus baseline, and 3 hours minus baseline

Population: 1 participant's data excluded as baseline data did not meet quality control metrics

Change from Baseline in Cerebral Blood Flow Global at 1, 2 and 3 Hours Post Lipid Drink

Outcome measures

Measure	Intervention n=29 Participants Only one arm of study Lipid drink: 100 mls of heavy cream
Cerebral Blood Flow Change Scores 1 hour change score	-1.8 ml/100g/min Standard Error 3.4
Cerebral Blood Flow Change Scores 2 hour change score	-2.2 ml/100g/min Standard Error 3.5
Cerebral Blood Flow Change Scores 3 hour change score	-2.4 ml/100g/min Standard Error 3.1

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Hanson

University of Washington

Phone: 206-897-5393

Email: hansonaj@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place