Trial Outcomes & Findings for Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL (NCT NCT02998918)
NCT ID: NCT02998918
Last Updated: 2023-11-18
Results Overview
VCAM-1 expression in HDL plasma will be measured at baseline, and after one week of supplementation for each supplement. Differences in one-week changes in inflammation between each supplement will be compared.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
One week
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Group 1: PolyResveratrol Then Curcumin Supplementation
Week 1 Polyresveratrol supplementation: Group 1 participants take 500 mg of PolyResveratrol (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene; Thorne Research) twice daily for one week. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
Weeks 2-3 Washout period: After the one week polyresveratrol supplementation period, the subjects go through a 2-week washout period with no supplementation.
Week 4 Curcumin supplementation: In this cross-over trial, group 1 participants take 500 mg of Curcumin phytosome twice daily for one week during week 4. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
|
Group 2: Curcumin Followed by Polyresveratrol Supplementation
Week 4 Curcumin supplementation: Group 2 participants take 500 mg of Curcumin phytosome twice daily for one week. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
Weeks 2-3 Washout period: After the one week Curcumin supplementation period, the subjects go through a 2-week washout period with no supplementation.
Week 4 Polyresveratrol supplementation: Group 2 participants take 500 mg of PolyResveratrol (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene; Thorne Research) twice daily for one week during the 4th week of the study. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
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|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: PolyResveratrol Then Curcumin Supplementation
Week 1 Polyresveratrol supplementation: Group 1 participants take 500 mg of PolyResveratrol (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene; Thorne Research) twice daily for one week. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
Weeks 2-3 Washout period: After the one week polyresveratrol supplementation period, the subjects go through a 2-week washout period with no supplementation.
Week 4 Curcumin supplementation: In this cross-over trial, group 1 participants take 500 mg of Curcumin phytosome twice daily for one week during week 4. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
|
Group 2: Curcumin Followed by Polyresveratrol Supplementation
Week 4 Curcumin supplementation: Group 2 participants take 500 mg of Curcumin phytosome twice daily for one week. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
Weeks 2-3 Washout period: After the one week Curcumin supplementation period, the subjects go through a 2-week washout period with no supplementation.
Week 4 Polyresveratrol supplementation: Group 2 participants take 500 mg of PolyResveratrol (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene; Thorne Research) twice daily for one week during the 4th week of the study. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
Baseline characteristics by cohort
| Measure |
Group 1: PolyResveratrol Then Curcumin Supplementation
n=11 Participants
Group 1 consumed 1 mg/day (one dose of 500 mg/two capsules in morning and two capsules/500 mg at night) of Polyresveratrol-SR for one week in phase 1 then after a 2-week washout period consumed 1 mg/day (one dose of 500 mg/two capsules in morning and one dose of 500 mg at night) of Meriva 500-SF (curcumin phytosome) for one week during phase 2 of the crossover trial
|
Group 2: Curcumin Then PolyResveratrol Supplementation
n=10 Participants
Group 2 consumed 1 mg/day (one dose of 500 mg/two capsules in morning and two capsules/500 mg at night) of Meriva 500-SF (curcumin phytosome) for one week in phase 1 then after a 2-week washout period consumed 1 mg/day (one dose of 500 mg/two capsules in morning and one dose of 500 mg at night) of Polyresveratrol-SR for one week during phase 2 of the crossover trial
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
26.8 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
30.0 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
28.0 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
BMI
|
24.2 kg/m^2
STANDARD_DEVIATION 4.5 • n=99 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 5.0 • n=107 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: One weekVCAM-1 expression in HDL plasma will be measured at baseline, and after one week of supplementation for each supplement. Differences in one-week changes in inflammation between each supplement will be compared.
Outcome measures
| Measure |
Group 1: PolyResveratrol Then Curcumin Supplementation
n=11 Participants
Group 1 consumed 1 mg/day (one dose of 500 mg/two capsules in morning and two capsules/500 mg at night) of Polyresveratrol-SR for one week in phase 1 then after a 2-week washout period consumed 1 mg/day (one dose of 500 mg/two capsules in morning and one dose of 500 mg at night) of Meriva 500-SF (curcumin phytosome) for one week during phase 2 of the crossover trial
|
Group 2: Curcumin Then PolyResveratrol Supplementation
n=10 Participants
Group 2 consumed 1 mg/day (one dose of 500 mg/two capsules in morning and two capsules/500 mg at night) of Meriva 500-SF (curcumin phytosome) for one week in phase 1 then after a 2-week washout period consumed 1 mg/day (one dose of 500 mg/two capsules in morning and one dose of 500 mg at night) of Polyresveratrol-SR for one week during phase 2 of the crossover trial
|
|---|---|---|
|
Inflammation Change: HDL Plasma
|
NA AU
Standard Deviation NA
The assays for this measure would not produce valid/reliable results on our stored specimens. Thus, we will not be reporting data for this outcome.
|
NA AU
Standard Deviation NA
The assays for this measure would not produce valid/reliable results on our stored specimens. Thus, we will not be reporting data for this outcome.
|
Adverse Events
PolyResveratrol Supplementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Curcumin Supplementation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place