Trial Outcomes & Findings for RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial) (NCT NCT02246660)
NCT ID: NCT02246660
Last Updated: 2018-04-30
Results Overview
Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Baseline and 6 month follow-up
Results posted on
2018-04-30
Participant Flow
Participant milestones
| Measure |
Resveratrol - 500 mg/Day
The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Resveratrol - 125 mg/Day
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Placebo
Placebo will be taken orally for 6 months.
Placebo: Placebo will be taken orally for 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
22
|
|
Overall Study
COMPLETED
|
23
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Resveratrol - 500 mg/Day
The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Resveratrol - 125 mg/Day
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Placebo
Placebo will be taken orally for 6 months.
Placebo: Placebo will be taken orally for 6 months.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)
Baseline characteristics by cohort
| Measure |
Resveratrol - 500 mg/Day
n=23 Participants
The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Resveratrol - 125 mg/Day
n=21 Participants
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Placebo
n=22 Participants
Placebo will be taken orally for 6 months.
Placebo: Placebo will be taken orally for 6 months.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
73.6 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
74.1 years
STANDARD_DEVIATION 6.1 • n=206 Participants
|
74.4 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ankle Brachial Index
|
0.69 Ratio
STANDARD_DEVIATION 0.23 • n=99 Participants
|
0.68 Ratio
STANDARD_DEVIATION 0.15 • n=107 Participants
|
0.63 Ratio
STANDARD_DEVIATION 0.13 • n=206 Participants
|
0.67 Ratio
STANDARD_DEVIATION 0.18 • n=7 Participants
|
|
Current Smoker
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Former Smoker
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
BMI
|
29.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=99 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 5.4 • n=107 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=206 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 5.3 • n=7 Participants
|
|
Myocardial Infarction
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Heart Failure
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Stroke
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Angina
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Pulmonary Disease
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Cancer
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Diabetes
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Intermittent Claudication
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Exertional leg symptoms not consistent with classical intermittent claudication
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Asymptomatic
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
6-Minute Walk Distance
|
357 meters
STANDARD_DEVIATION 58 • n=99 Participants
|
370 meters
STANDARD_DEVIATION 65 • n=107 Participants
|
354 meters
STANDARD_DEVIATION 70 • n=206 Participants
|
360 meters
STANDARD_DEVIATION 63 • n=7 Participants
|
|
Total Treadmill Distance
|
529.4 meters
STANDARD_DEVIATION 268.6 • n=99 Participants
|
492.8 meters
STANDARD_DEVIATION 261.2 • n=107 Participants
|
443.3 meters
STANDARD_DEVIATION 242.4 • n=206 Participants
|
488.4 meters
STANDARD_DEVIATION 255.9 • n=7 Participants
|
|
Treadmill distance at onset of leg symptom
|
271.1 meters
STANDARD_DEVIATION 217.7 • n=99 Participants
|
226.6 meters
STANDARD_DEVIATION 123.4 • n=107 Participants
|
218.0 meters
STANDARD_DEVIATION 147.3 • n=206 Participants
|
239.1 meters
STANDARD_DEVIATION 168.5 • n=7 Participants
|
|
Cilostazol use
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Pentoxifylline use
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Antiplatelet therapy use
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Statin use
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Reported walking for exercise 3 or more times/week
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 month follow-upSix month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.
Outcome measures
| Measure |
Resveratrol - 500 mg/Day
n=23 Participants
The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Resveratrol - 125 mg/Day
n=20 Participants
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Placebo
n=21 Participants
Placebo will be taken orally for 6 months.
Placebo: Placebo will be taken orally for 6 months.
|
|---|---|---|---|
|
6-Minute Walk Distance, Meters
|
-12.8 meters
Standard Deviation 7.5
|
4.6 meters
Standard Deviation 8.1
|
-12.3 meters
Standard Deviation 7.9
|
Adverse Events
Resveratrol - 500 mg/Day
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Resveratrol - 125 mg/Day
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Resveratrol - 500 mg/Day
n=23 participants at risk
The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Resveratrol - 125 mg/Day
n=21 participants at risk
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Placebo
n=22 participants at risk
Placebo will be taken orally for 6 months.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/23
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Coronary stenosis
|
0.00%
0/23
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Immune system disorders
Allergy to lisinopril
|
0.00%
0/23
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Toe amputation
|
0.00%
0/23
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urologic procedure
|
4.3%
1/23 • Number of events 1
|
0.00%
0/21
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
4.3%
1/23 • Number of events 1
|
0.00%
0/21
|
0.00%
0/22
|
|
Vascular disorders
Lower extremity revascularization
|
4.3%
1/23 • Number of events 1
|
0.00%
0/21
|
0.00%
0/22
|
|
Surgical and medical procedures
Elective plastic surgery
|
4.3%
1/23 • Number of events 1
|
0.00%
0/21
|
0.00%
0/22
|
Other adverse events
| Measure |
Resveratrol - 500 mg/Day
n=23 participants at risk
The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Resveratrol - 125 mg/Day
n=21 participants at risk
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
|
Placebo
n=22 participants at risk
Placebo will be taken orally for 6 months.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
13.0%
3/23
|
9.5%
2/21
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
8.7%
2/23
|
0.00%
0/21
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Hand cramp
|
4.3%
1/23
|
0.00%
0/21
|
4.5%
1/22
|
|
General disorders
Swelling
|
4.3%
1/23
|
4.8%
1/21
|
9.1%
2/22
|
|
General disorders
Walking difficulty
|
4.3%
1/23
|
0.00%
0/21
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/23
|
4.8%
1/21
|
0.00%
0/22
|
|
Infections and infestations
Fever
|
0.00%
0/23
|
0.00%
0/21
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23
|
0.00%
0/21
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/23
|
0.00%
0/21
|
4.5%
1/22
|
|
Nervous system disorders
Dizziness/headache
|
8.7%
2/23
|
0.00%
0/21
|
0.00%
0/22
|
|
Gastrointestinal disorders
Black stool
|
4.3%
1/23
|
0.00%
0/21
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
2/23
|
0.00%
0/21
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Weight loss
|
4.3%
1/23
|
0.00%
0/21
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea/vomiting
|
26.1%
6/23
|
19.0%
4/21
|
9.1%
2/22
|
|
Gastrointestinal disorders
Diarrhea
|
60.9%
14/23
|
33.3%
7/21
|
50.0%
11/22
|
|
General disorders
Abdominal discomfort
|
52.2%
12/23
|
33.3%
7/21
|
13.6%
3/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place