Trial Outcomes & Findings for Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress (NCT NCT01267227)
NCT ID: NCT01267227
Last Updated: 2018-01-10
Results Overview
Increase in low density lipoprotein (LDL)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Baseline and 6-8 weeks
Results posted on
2018-01-10
Participant Flow
Medical clinic
Participant milestones
| Measure |
High Dose
Pterostilbene 125 mg twice daily
|
Low Dose
Pterostilbene 50 mg twice daily
|
Low Dose Combination
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
|
Placebo
Matching placebo twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Baseline characteristics by cohort
| Measure |
High Dose
n=20 Participants
Pterostilbene 125 mg twice daily
|
Low Dose
n=20 Participants
Pterostilbene 50 mg twice daily
|
Low Dose Combination
n=20 Participants
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
|
Placebo
n=20 Participants
Matching placebo twice daily
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
53.6 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6-8 weeksIncrease in low density lipoprotein (LDL)
Outcome measures
| Measure |
High Dose
n=20 Participants
Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
|
Low Dose
n=20 Participants
Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
|
Low Dose Combination
n=20 Participants
Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
|
Placebo
n=20 Participants
Matching placebo twice daily. Unadjusted change from baseline.
|
|---|---|---|---|---|
|
LDL
|
19.67 mg/dL
Interval 5.28 to 34.05
|
20.04 mg/dL
Interval 5.68 to 34.4
|
5.33 mg/dL
Interval -9.16 to 19.82
|
0 mg/dL
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 6-8 weeksReduction in systolic blood pressure versus placebo
Outcome measures
| Measure |
High Dose
n=20 Participants
Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
|
Low Dose
n=20 Participants
Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
|
Low Dose Combination
n=20 Participants
Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
|
Placebo
n=20 Participants
Matching placebo twice daily. Unadjusted change from baseline.
|
|---|---|---|---|---|
|
Blood Pressure
|
7.77 mmHg
Interval 2.38 to 13.17
|
3.67 mmHg
Interval -1.74 to 9.09
|
6.72 mmHg
Interval 1.25 to 12.18
|
0 mmHg
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 6-8 weeksNumber of participants with adverse effects as a measure of safety
Outcome measures
| Measure |
High Dose
n=20 Participants
Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
|
Low Dose
n=20 Participants
Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
|
Low Dose Combination
n=20 Participants
Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
|
Placebo
n=20 Participants
Matching placebo twice daily. Unadjusted change from baseline.
|
|---|---|---|---|---|
|
Subjective Adverse Effects
|
5 participants
|
3 participants
|
2 participants
|
2 participants
|
Adverse Events
High Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Dose Combination
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose
n=20 participants at risk
Pterostilbene 125 mg twice daily
|
Low Dose
n=20 participants at risk
Pterostilbene 50 mg twice daily
|
Low Dose Combination
n=20 participants at risk
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
|
Placebo
n=20 participants at risk
Matching placebo twice daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
GI
|
20.0%
4/20 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Itching
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure of the submitted materials approved per contractual agreement.
- Publication restrictions are in place
Restriction type: OTHER