Trial Outcomes & Findings for Choline and Cardiometabolic Health (NCT NCT04764162)

NCT ID: NCT04764162

Last Updated: 2025-05-31

Results Overview

Participants will complete a 2-hour glucose tolerance test at baseline, immediately following the first intervention, after a 2-week washout, and immediately following the second intervention. A catheter will be placed in one of the participant's arms. After a baseline blood draw to measure fasting levels of glucose, insulin, cholesterol and other factors, participants will drink a glucose beverage (75 g). Blood will be collected in small amounts (less than one half teaspoon) at eight timepoints over a 2-hour period. Insulin sensitivity will be calculated using Matsuda's index (a ratio with no units). This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Calculated difference between the baseline and 4-week testing session for each intervention
• Results posted on: 2025-05-31

Participant Flow

14 individuals were screened and 10 were randomized. Those not randomized voluntarily withdrew from the study.

4 enrolled participants voluntarily withdrew from the study and did not complete any pre-testing sessions before their first assigned intervention.

Participant milestones

Measure	Choline, Then Placebo Participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions.	Placebo, Then Choline Participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions.
Overall Study STARTED	3	7
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Choline, Then Placebo Participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions.	Placebo, Then Choline Participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions.
Overall Study Did not complete oral glucose tolerance tests due to low BP. Did complete other study measures.	0	1

Baseline Characteristics

Choline and Cardiometabolic Health

Baseline characteristics by cohort

Measure	Choline, Then Placebo n=3 Participants Participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions	Placebo, Then Choline n=7 Participants Participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions.	Total n=10 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 16 • n=5 Participants	50 years STANDARD_DEVIATION 17 • n=7 Participants	48 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants
Body Mass Index	28.3 kg/m2 STANDARD_DEVIATION 3.4 • n=5 Participants	24.2 kg/m2 STANDARD_DEVIATION 2.96 • n=7 Participants	25.5 kg/m2 STANDARD_DEVIATION 3.5 • n=5 Participants
Systolic blood pressure	121 mmHg STANDARD_DEVIATION 9 • n=5 Participants	119 mmHg STANDARD_DEVIATION 14 • n=7 Participants	120 mmHg STANDARD_DEVIATION 13 • n=5 Participants
Diastolic blood pressure	75 mmHg STANDARD_DEVIATION 9 • n=5 Participants	72 mmHg STANDARD_DEVIATION 6 • n=7 Participants	73 mmHg STANDARD_DEVIATION 7 • n=5 Participants
Triglycerides	113 mg/dL STANDARD_DEVIATION 63 • n=5 Participants	117 mg/dL STANDARD_DEVIATION 66 • n=7 Participants	116 mg/dL STANDARD_DEVIATION 62 • n=5 Participants
Total cholesterol	183 mg/dL STANDARD_DEVIATION 36 • n=5 Participants	200 mg/dL STANDARD_DEVIATION 35 • n=7 Participants	195 mg/dL STANDARD_DEVIATION 34 • n=5 Participants
HDL cholesterol	42 mg/dL STANDARD_DEVIATION 3 • n=5 Participants	55 mg/dL STANDARD_DEVIATION 20 • n=7 Participants	51 mg/dL STANDARD_DEVIATION 17 • n=5 Participants
LDL cholesterol	120 mg/dL STANDARD_DEVIATION 22 • n=5 Participants	122 mg/dL STANDARD_DEVIATION 22 • n=7 Participants	121 mg/dL STANDARD_DEVIATION 21 • n=5 Participants
Glucose	95 mg/dL STANDARD_DEVIATION 2 • n=5 Participants	90 mg/dL STANDARD_DEVIATION 5 • n=7 Participants	92 mg/dL STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: Calculated difference between the baseline and 4-week testing session for each intervention

Population: All participants received each supplementation intervention during their respective cross-over randomization assignment. Therefore, Outcome Measures are reported per intervention.

Participants will complete a 2-hour glucose tolerance test at baseline, immediately following the first intervention, after a 2-week washout, and immediately following the second intervention. A catheter will be placed in one of the participant's arms. After a baseline blood draw to measure fasting levels of glucose, insulin, cholesterol and other factors, participants will drink a glucose beverage (75 g). Blood will be collected in small amounts (less than one half teaspoon) at eight timepoints over a 2-hour period. Insulin sensitivity will be calculated using Matsuda's index (a ratio with no units). This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).

Outcome measures

Measure	Choline n=9 Participants Participants will consume 1000 mg (2 x 500 mg) of choline per day for 4 weeks, including post-testing sessions.	Placebo n=9 Participants Participants will consume 1000 mg (2 x 500 mg) of placebo (maltodextrin) per day for 4 weeks, including post-testing sessions.
Change From Baseline in Insulin Sensitivity at 4 Weeks	0.28 Calculated Ratio - No units Standard Deviation 0.8	-0.29 Calculated Ratio - No units Standard Deviation 0.45

SECONDARY outcome

Timeframe: Difference in 24-hour glucose levels during free living at baseline and 4 weeks

Population: All participants received each supplementation intervention during their respective cross-over randomization assignment. Therefore, Outcome Measures are reported per intervention.

Glucose will be monitored by a Continuous Glucose Monitor (CGM) sensor (Enlite Sensor; Medtronic, Inc. or FreeStyle Libre Pro; Abbott) and this will be placed on the participant's abdomen or back of the upper arm in order to measure glucose continuously. The measured glucose levels will be assessed by an iPro2 Professional CGM; Medtronic, Inc. or FreeStyle Libre Pro reader; Abbott; and the CGM will be worn for 4 consecutive days. This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).

Outcome measures

Measure	Choline n=9 Participants Participants will consume 1000 mg (2 x 500 mg) of choline per day for 4 weeks, including post-testing sessions.	Placebo n=9 Participants Participants will consume 1000 mg (2 x 500 mg) of placebo (maltodextrin) per day for 4 weeks, including post-testing sessions.
Change in 24-hour Area Under the Curve for Glucose Levels After Supplementation	7032.5 mg/dL per day Standard Deviation 10709.5	-2685 mg/dL per day Standard Deviation 17213.2

Adverse Events

Choline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Kevin Davy

Virginia Tech

Phone: (540)231-3487

Email: kdavy@vt.edu

Results disclosure agreements

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