Trial Outcomes & Findings for Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients (NCT NCT04030247)

NCT ID: NCT04030247

Last Updated: 2022-04-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: month 3
• Results posted on: 2022-04-27

Participant Flow

Participant milestones

Measure	Plant Sterol South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Overall Study STARTED	50
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Plant Sterol South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	13

Baseline Characteristics

Participants with available data are included in the analysis

Baseline characteristics by cohort

Measure	Plant Sterol n=33 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Age, Continuous	45.33 years STANDARD_DEVIATION 8.3 • n=33 Participants
Sex: Female, Male Female	21 Participants n=33 Participants
Sex: Female, Male Male	12 Participants n=33 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=33 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=33 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=33 Participants
Race (NIH/OMB) Asian	33 Participants n=33 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=33 Participants
Race (NIH/OMB) Black or African American	0 Participants n=33 Participants
Race (NIH/OMB) White	0 Participants n=33 Participants
Race (NIH/OMB) More than one race	0 Participants n=33 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=33 Participants
Region of Enrollment United States	33 Participants n=33 Participants
Low Density Lipoprotein-Cholesterol (LDL-C)	154 mg/dL STANDARD_DEVIATION 24 • n=33 Participants
Total Cholesterol	221 mg/dL STANDARD_DEVIATION 34 • n=33 Participants
Calculated LDL-C	154 mg/dL STANDARD_DEVIATION 24 • n=33 Participants
High Density Lipoprotein-Cholesterol (HDL-C)	50 mg/dL STANDARD_DEVIATION 15 • n=33 Participants
Triglycerides	137 mg/dL STANDARD_DEVIATION 52 • n=33 Participants
Fasting Glucose	98 mg/dL STANDARD_DEVIATION 11 • n=24 Participants • Participants with available data are included in the analysis
Fasting Insulin	11.3 mcU/mL STANDARD_DEVIATION 7 • n=16 Participants • Participants with available data are included in the analysis
Hemoglobin A1C (HbA1c)	5.5 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.3 • n=22 Participants • Participants with available data are included in the analysis

PRIMARY outcome

Timeframe: month 3

Population: Participants who completed the protocol are included in the analysis.

Outcome measures

Measure	Plant Sterol n=33 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
LDL-C at Month 3	145 mg/dL Standard Deviation 20

SECONDARY outcome

Timeframe: month 3

Population: Participants who completed the protocol are included in the analysis.

Outcome measures

Measure	Plant Sterol n=33 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Total Cholesterol at Month 3	216 mg/dL Standard Deviation 29

SECONDARY outcome

Timeframe: month 3

Population: Participants who completed the protocol are included in the analysis.

Outcome measures

Measure	Plant Sterol n=33 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Calculated LDL-C at Month 3	145 mg/dL Standard Deviation 20

SECONDARY outcome

Timeframe: month 3

Population: Participants who completed the protocol are included in the analysis.

Outcome measures

Measure	Plant Sterol n=33 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
HDL-C at Month 3	50 mg/dL Standard Deviation 13

SECONDARY outcome

Timeframe: month 3

Population: Participants who completed the protocol are included in the analysis.

Outcome measures

Measure	Plant Sterol n=33 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Triglycerides at Month 3	142 mg/dL Standard Deviation 58

SECONDARY outcome

Timeframe: month 3

Population: Participants with available data are included in the analysis.

Outcome measures

Measure	Plant Sterol n=24 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Fasting Glucose at Month 3	96 mg/dL Standard Deviation 8

SECONDARY outcome

Timeframe: month 3

Population: Participants with available data are included in the analysis.

Outcome measures

Measure	Plant Sterol n=17 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
Fasting Insulin at Month 3	10.2 mcU/mL Standard Deviation 5.9

SECONDARY outcome

Timeframe: month 3

Population: Participants with available data are included in the analysis.

Outcome measures

Measure	Plant Sterol n=22 Participants South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
HbA1c at Month 3	5.5 Percentage of glycosylated hemoglobin Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.

% change in baseline measurement non-HDL-C to 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.

% change in baseline measurement Lp(a) to 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.

% change in baseline measurement Apoprotein B-100 to 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.

% change in baseline measurement Apoprotein A1 to 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.

% change in baseline measurement ratio, ApoB-100/Apo A1 to 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.

% change in baseline measurement in C-reactive protein to 3 months

Outcome measures

Outcome data not reported

Adverse Events

Plant Sterol

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

Rajesh Dash, MD

Stanford University

Phone: 650-725-7087

Email: rdash@stanford.edu

Results disclosure agreements

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