Trial Outcomes & Findings for Resveratrol and Exercise to Treat Functional Limitations in Late Life (NCT NCT02523274)
NCT ID: NCT02523274
Last Updated: 2022-01-13
Results Overview
Walking speed is assessed by asking the participants to walk at their usual pace over a 4 m course. Participants are to stand with both feet touching the starting line and to start walking after a verbal command is given, and the time needed to complete the entire distance will be recorded. The faster of two walks will be used and changes between the groups at baseline and 12 weeks will be assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Change at Baseline to 12 weeks
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
500 mg/day resveratrol taken orally via capsule following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
Resveratrol 1000 mg/Day
1000 mg/day resveratrol taken orally via capsule following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resveratrol and Exercise to Treat Functional Limitations in Late Life
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=20 Participants
500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
Resveratrol 1000 mg/Day
n=20 Participants
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.72 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 5.63 • n=7 Participants
|
73.8 years
STANDARD_DEVIATION 5.73 • n=5 Participants
|
74.1 years
STANDARD_DEVIATION 5.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Body Mass Index
|
31.1 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
31.3 kg/m^2
STANDARD_DEVIATION 7.6 • n=7 Participants
|
32 kg/m^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 6.7 • n=4 Participants
|
|
Waist Circumference
|
98.4 cm
STANDARD_DEVIATION 26.1 • n=5 Participants
|
105 cm
STANDARD_DEVIATION 20.3 • n=7 Participants
|
103 cm
STANDARD_DEVIATION 17.1 • n=5 Participants
|
102.1 cm
STANDARD_DEVIATION 21.2 • n=4 Participants
|
|
Systolic Blood Pressure
|
140 mmHg
STANDARD_DEVIATION 13.7 • n=5 Participants
|
145 mmHg
STANDARD_DEVIATION 15.1 • n=7 Participants
|
133 mmHg
STANDARD_DEVIATION 9.6 • n=5 Participants
|
139.3 mmHg
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Diastolic Blood Pressure
|
79.3 mmHg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
82.4 mmHg
STANDARD_DEVIATION 9.5 • n=7 Participants
|
78.2 mmHg
STANDARD_DEVIATION 8.2 • n=5 Participants
|
80.0 mmHg
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Six-minute walk test
|
1.0 m/s
STANDARD_DEVIATION 0.02 • n=5 Participants
|
1.0 m/s
STANDARD_DEVIATION 0.02 • n=7 Participants
|
1.0 m/s
STANDARD_DEVIATION 0.02 • n=5 Participants
|
1.0 m/s
STANDARD_DEVIATION 0.02 • n=4 Participants
|
|
SPPB Total Score
|
10.3 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 0.2 • n=7 Participants
|
10.3 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
10.3 units on a scale
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Peak Knee Torque
|
73.3 Newtons-Meter
STANDARD_DEVIATION 2.7 • n=5 Participants
|
73 Newtons-Meter
STANDARD_DEVIATION 2.6 • n=7 Participants
|
71.7 Newtons-Meter
STANDARD_DEVIATION 2.8 • n=5 Participants
|
72.7 Newtons-Meter
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Late-Life Function and Disability Instrument
|
73.6 Scores on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
73.8 Scores on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
73.6 Scores on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
73.7 Scores on a scale
STANDARD_DEVIATION 1.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change at Baseline to 12 weeksWalking speed is assessed by asking the participants to walk at their usual pace over a 4 m course. Participants are to stand with both feet touching the starting line and to start walking after a verbal command is given, and the time needed to complete the entire distance will be recorded. The faster of two walks will be used and changes between the groups at baseline and 12 weeks will be assessed.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=18 Participants
500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
Resveratrol 1000 mg/Day
n=18 Participants
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
Walking Speed
|
-0.04 m/s
Interval -0.1 to 0.03
|
-0.03 m/s
Interval -0.09 to 0.04
|
0.04 m/s
Interval -0.02 to 0.11
|
SECONDARY outcome
Timeframe: Change between baseline to 12 weeksInvestigators will assess lower-extremity function by asking the participants to perform a series of tasks including: walking at their usual pace over a 4 m course, repeated chair stands, and a balance test. Each task is scored from 0 to 4, with 4 indicating best level of performance and 0 the inability to complete the test. A summary score (0-12) is then calculated. Higher score on the scale is reflective of higher function and lower score reflects lower functioning. Changes between the groups at baseline and 12 weeks will be assessed.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=18 Participants
500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
Resveratrol 1000 mg/Day
n=18 Participants
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
Short Physical Performance Battery (SPPB).
|
0.38 score on a scale
Interval -0.17 to 0.93
|
0.25 score on a scale
Interval -0.3 to 0.8
|
0.13 score on a scale
Interval -0.42 to 0.69
|
SECONDARY outcome
Timeframe: Change between baseline and 12 weeksIsokinetic strength of the dominant limb will be assessed by a standard dynamometer and changes between the groups at baseline and 12 weeks will be assessed.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=18 Participants
500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
Resveratrol 1000 mg/Day
n=18 Participants
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
Isokinetic Strength.
|
-3.24 Newtons-Meters
Interval -9.7 to 3.23
|
10.5 Newtons-Meters
Interval 4.28 to 16.7
|
6.15 Newtons-Meters
Interval -0.31 to 12.6
|
SECONDARY outcome
Timeframe: Change between Baseline and 12 weeksInvestigators will assess exercise capacity of participants using the six-minute (6-min) walk test to assess change in meters walked between the groups at baseline and 12 weeks.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=18 Participants
500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
Resveratrol 1000 mg/Day
n=18 Participants
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
6-minute Walk Test
|
9.34 Meters
Interval -9.02 to 27.7
|
22.9 Meters
Interval 4.18 to 41.6
|
33.1 Meters
Interval 13.8 to 52.4
|
SECONDARY outcome
Timeframe: Change at Baseline to 12 weeksThe instrument includes 16 tasks representing a broad range of disability indicators that assesses both frequency of doing a task and perceived limitation. The instrument uses a scale from 0 to 100, with higher scores indicating higher levels of function.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=18 Participants
500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages
|
Resveratrol 1000 mg/Day
n=18 Participants
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
Late-Life Function and Disability Instrument
|
4.77 Score on a scale
Interval 0.06 to 9.49
|
5.72 Score on a scale
Interval 0.93 to 10.5
|
3.36 Score on a scale
Interval -1.5 to 8.22
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Resveratrol 500 mg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Resveratrol 1000 mg/Day
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=20 participants at risk
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
Resveratrol 1000 mg/Day
n=20 participants at risk
1500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
Cardiac disorders
Heart Attack
|
5.0%
1/20 • Number of events 20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose
|
Resveratrol 500 mg/Day
n=20 participants at risk
1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
Resveratrol 1000 mg/Day
n=20 participants at risk
1500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Issues
|
15.0%
3/20 • 12 weeks
|
10.0%
2/20 • 12 weeks
|
20.0%
4/20 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
5.0%
1/20 • 12 weeks
|
15.0%
3/20 • 12 weeks
|
10.0%
2/20 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Renal and urinary disorders
Blood Sugar
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Hepatobiliary disorders
Bladder Infection
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Vascular disorders
Elevated Blood Pressure
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Cardiac disorders
Heart Attack
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Light headedness
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/20 • 12 weeks
|
10.0%
2/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place