Trial Outcomes & Findings for Phytosterols, Ezetimibe, and Cholesterol Metabolism (NCT NCT00863265)
NCT ID: NCT00863265
Last Updated: 2018-06-01
Results Overview
Milligrams of fecal cholesterol and cholesterol metabolites excreted per day
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
22 participants
Primary outcome timeframe
At the end of week 3 on each diet
Results posted on
2018-06-01
Participant Flow
175 subjects were screened and 153 were excluded prior to randomization. 75 did not meet screening criteria, 39 declined to participate and 39 were not able to perform functions needed for the study. 22 Subjects were randomized and 21 completed the study.
Participant milestones
| Measure |
Crossover Order ABC
Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.
A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols.
|
Crossover Order BCA
Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.
A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols.
|
Crossover Order BAC
Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.
A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols.
|
Crossover Order ACB
Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.
A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols.
|
Crossover Order CAB
Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.
A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols.
|
Crossover Order CBA
Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.
A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
4
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phytosterols, Ezetimibe, and Cholesterol Metabolism
Baseline characteristics by cohort
| Measure |
All Study Participants
n=22 Participants
All study participants.
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
race · white
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
race · asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
race · hispanic
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of week 3 on each dietPopulation: Healthy subjects
Milligrams of fecal cholesterol and cholesterol metabolites excreted per day
Outcome measures
| Measure |
Phytosterol-Deficient Diet
n=21 Participants
Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Diet Plus Ezetimibe
n=21 Participants
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus phytosterol placebo.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Diet Plus Ezetimibe Plus Phytosterols
n=21 Participants
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus 2000 mg/day of phytosterols.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
|---|---|---|---|
|
Cholesterol Excretion
|
505 mg per day
Interval 386.0 to 625.0
|
794 mg per day
Interval 615.0 to 973.0
|
962 mg per day
Interval 757.0 to 1168.0
|
PRIMARY outcome
Timeframe: Determined on the final 5 days of each dietary periodPercent of intestinal cholesterol absorbed. Intestinal cholesterol is comprised of dietary cholesterol intake and endogenous cholesterol secreted into the intestinal lumen. Cholesterol absorption is the percent of intestinal cholesterol that is taken back up into the body and excluded from fecal excretion. It is also referred to as the efficiency of intestinal cholesterol absorption.
Outcome measures
| Measure |
Phytosterol-Deficient Diet
n=21 Participants
Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Diet Plus Ezetimibe
n=21 Participants
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus phytosterol placebo.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Diet Plus Ezetimibe Plus Phytosterols
n=21 Participants
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus 2000 mg/day of phytosterols.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
|---|---|---|---|
|
Percent Cholesterol Absorption
|
69.0 Percent
Interval 61.8 to 76.2
|
46.2 Percent
Interval 38.5 to 53.9
|
32.6 Percent
Interval 26.9 to 38.3
|
PRIMARY outcome
Timeframe: At the end of week 3 on each dietPopulation: Healthy subjects
Outcome measures
| Measure |
Phytosterol-Deficient Diet
n=21 Participants
Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Diet Plus Ezetimibe
n=21 Participants
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus phytosterol placebo.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Diet Plus Ezetimibe Plus Phytosterols
n=21 Participants
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus 2000 mg/day of phytosterols.
Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
|---|---|---|---|
|
LDL Cholesterol
|
129 mg/deciliter
Interval 116.0 to 142.0
|
108 mg/deciliter
Interval 97.0 to 119.0
|
101 mg/deciliter
Interval 90.0 to 112.0
|
Adverse Events
Phytosterol-Deficient Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet Plus Ezetimibe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet Plus Ezetimibe Plus Phytosterols
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
Richard E. Ostlund MD
Washington University School of Medicine
Phone: 314-362-3516
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place