Trial Outcomes & Findings for Resveratrol to Enhance Vitality and Vigor in Elders (NCT NCT02123121)
NCT ID: NCT02123121
Last Updated: 2024-04-26
Results Overview
Change in mitochondrial respiration (State 3) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 90 Days
Results posted on
2024-04-26
Participant Flow
Participant milestones
| Measure |
Vegetable Cellulose
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
19
|
|
Overall Study
COMPLETED
|
18
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dropout occurred.
Baseline characteristics by cohort
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.72 years
STANDARD_DEVIATION 5.94 • n=20 Participants
|
73.4 years
STANDARD_DEVIATION 5.63 • n=21 Participants
|
73.18 years
STANDARD_DEVIATION 5.78 • n=19 Participants
|
74.1 years
STANDARD_DEVIATION 5.78 • n=60 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=19 Participants
|
37 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=19 Participants
|
23 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
16 Participants
n=20 Participants
|
18 Participants
n=21 Participants
|
13 Participants
n=19 Participants
|
47 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=20 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=19 Participants
|
10 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=60 Participants
|
|
Marital Status
Never Married
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=60 Participants
|
|
Marital Status
Married
|
10 Participants
n=20 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=19 Participants
|
26 Participants
n=60 Participants
|
|
Marital Status
Separated/Divorced/Widowed
|
8 Participants
n=20 Participants
|
10 Participants
n=21 Participants
|
13 Participants
n=19 Participants
|
31 Participants
n=60 Participants
|
|
Marital Status
Other
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=60 Participants
|
|
Live Alone
Yes
|
6 Participants
n=20 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=19 Participants
|
18 Participants
n=60 Participants
|
|
Live Alone
No
|
14 Participants
n=20 Participants
|
16 Participants
n=21 Participants
|
12 Participants
n=19 Participants
|
42 Participants
n=60 Participants
|
|
Highest Level of Education
High School/Equivalent
|
5 Participants
n=20 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=19 Participants
|
14 Participants
n=60 Participants
|
|
Highest Level of Education
College
|
5 Participants
n=20 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=19 Participants
|
23 Participants
n=60 Participants
|
|
Highest Level of Education
Post-Graduate
|
7 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=19 Participants
|
20 Participants
n=60 Participants
|
|
Highest Level of Education
Other
|
3 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=60 Participants
|
|
Income
<$35,000
|
9 Participants
n=20 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=19 Participants
|
25 Participants
n=60 Participants
|
|
Income
$35,000-$74,999
|
7 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=19 Participants
|
24 Participants
n=60 Participants
|
|
Income
>=$75,000
|
3 Participants
n=20 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=19 Participants
|
7 Participants
n=60 Participants
|
|
Income
Don't Know/Refused
|
1 Participants
n=20 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=60 Participants
|
|
Body Mass Index
|
28.1 kg/m^2
STANDARD_DEVIATION 4.4 • n=20 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 3.8 • n=21 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 5.3 • n=19 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 4.5 • n=60 Participants
|
|
Physical Activity
|
44.0 minutes in moderate/vigorous activity
STANDARD_DEVIATION 26.5 • n=17 Participants • Dropout occurred.
|
44.2 minutes in moderate/vigorous activity
STANDARD_DEVIATION 22.5 • n=20 Participants • Dropout occurred.
|
49.2 minutes in moderate/vigorous activity
STANDARD_DEVIATION 22.5 • n=18 Participants • Dropout occurred.
|
45.8 minutes in moderate/vigorous activity
STANDARD_DEVIATION 23.8 • n=55 Participants • Dropout occurred.
|
|
Six Minute Walk
|
1.2 meters per second
STANDARD_DEVIATION 0.3 • n=20 Participants
|
1.2 meters per second
STANDARD_DEVIATION 0.2 • n=21 Participants
|
1.1 meters per second
STANDARD_DEVIATION 0.1 • n=19 Participants
|
1.2 meters per second
STANDARD_DEVIATION 0.2 • n=60 Participants
|
|
Short Physical Performance Battery (SPPB)
|
10.6 units on a scale (0-12)
STANDARD_DEVIATION 2.0 • n=20 Participants
|
11.0 units on a scale (0-12)
STANDARD_DEVIATION 1.5 • n=21 Participants
|
11.3 units on a scale (0-12)
STANDARD_DEVIATION 0.7 • n=19 Participants
|
11.0 units on a scale (0-12)
STANDARD_DEVIATION 1.4 • n=60 Participants
|
|
Knee Flexion
|
32.2 Peak Torque (nm)
STANDARD_DEVIATION 14.0 • n=20 Participants
|
37.4 Peak Torque (nm)
STANDARD_DEVIATION 15.8 • n=21 Participants
|
31.2 Peak Torque (nm)
STANDARD_DEVIATION 12.4 • n=19 Participants
|
33.6 Peak Torque (nm)
STANDARD_DEVIATION 13.7 • n=60 Participants
|
|
Waist Circumference
|
98.4 Centimeters
STANDARD_DEVIATION 9.3 • n=20 Participants
|
99.2 Centimeters
STANDARD_DEVIATION 10.8 • n=21 Participants
|
100.1 Centimeters
STANDARD_DEVIATION 18.4 • n=19 Participants
|
99.2 Centimeters
STANDARD_DEVIATION 12.8 • n=60 Participants
|
|
Glucose
|
98.6 mg/dL
STANDARD_DEVIATION 9.5 • n=20 Participants
|
92.4 mg/dL
STANDARD_DEVIATION 7.4 • n=21 Participants
|
94.3 mg/dL
STANDARD_DEVIATION 9.1 • n=19 Participants
|
95.1 mg/dL
STANDARD_DEVIATION 8.7 • n=60 Participants
|
|
Diastolic Blood Pressure
|
74.7 mmHg
STANDARD_DEVIATION 9.3 • n=20 Participants
|
77.0 mmHg
STANDARD_DEVIATION 8.6 • n=21 Participants
|
75.4 mmHg
STANDARD_DEVIATION 7.9 • n=19 Participants
|
75.4 mmHg
STANDARD_DEVIATION 8.6 • n=60 Participants
|
|
PGC-1 alpha
|
0.48 arbitrary units
STANDARD_DEVIATION 0.12 • n=20 Participants
|
0.52 arbitrary units
STANDARD_DEVIATION 0.16 • n=21 Participants
|
0.55 arbitrary units
STANDARD_DEVIATION 0.19 • n=19 Participants
|
0.52 arbitrary units
STANDARD_DEVIATION 0.16 • n=60 Participants
|
|
SIRT-1
|
0.7 arbitrary units
STANDARD_DEVIATION 0.25 • n=20 Participants
|
0.79 arbitrary units
STANDARD_DEVIATION 0.29 • n=21 Participants
|
0.71 arbitrary units
STANDARD_DEVIATION 0.18 • n=19 Participants
|
0.73 arbitrary units
STANDARD_DEVIATION 0.24 • n=60 Participants
|
|
SIRT-3
|
0.37 arbitrary units
STANDARD_DEVIATION 0.14 • n=20 Participants
|
0.42 arbitrary units
STANDARD_DEVIATION 0.14 • n=21 Participants
|
0.43 arbitrary units
STANDARD_DEVIATION 0.18 • n=19 Participants
|
0.41 arbitrary units
STANDARD_DEVIATION 0.15 • n=60 Participants
|
|
Mitochondrial DNA Content
|
384.3 ratio
STANDARD_DEVIATION 139.9 • n=20 Participants
|
409.1 ratio
STANDARD_DEVIATION 127.4 • n=21 Participants
|
329.3 ratio
STANDARD_DEVIATION 86.1 • n=19 Participants
|
374.2 ratio
STANDARD_DEVIATION 117.8 • n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 DaysChange in mitochondrial respiration (State 3) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days).
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Mitochondrial Respiration in Muscle
|
-3.05 nmol O2/s/mg wwt
Interval -9.9 to 3.81
|
-4.82 nmol O2/s/mg wwt
Interval -11.03 to 1.38
|
-4.56 nmol O2/s/mg wwt
Interval -12.07 to 2.94
|
PRIMARY outcome
Timeframe: Baseline to 90 daysPopulation: Population measured after participant dropout.
Change in cytochrome oxidase (COX) in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days).
Outcome measures
| Measure |
Vegetable Cellulose
n=13 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=17 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=11 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples
|
109.4 nmol/min/mg/protein
Standard Deviation 58.26
|
126.7 nmol/min/mg/protein
Standard Deviation 34.10
|
121.2 nmol/min/mg/protein
Standard Deviation 48.46
|
PRIMARY outcome
Timeframe: Baseline to 90 DaysChange in citrate synthase (CS) enzymes in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days).
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples
|
-0.02 nmol/min/mg protein
Interval -0.25 to 0.2
|
0.08 nmol/min/mg protein
Interval -0.13 to 0.29
|
-0.09 nmol/min/mg protein
Interval -0.34 to 0.16
|
PRIMARY outcome
Timeframe: Baseline and 90 DaysChange in mitochondrial DNA content in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days).
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Mitochondrial DNA Content in Muscle Samples
|
2.71 Ratio
Interval -43.58 to 49.01
|
7.13 Ratio
Interval -36.8 to 51.06
|
-7.31 Ratio
Interval -58.32 to 43.71
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in muscle protein levels, such as PGC-1α (primary outcome) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample.
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in PGC-1α Muscle Protein Levels
|
-0.10 arbitrary units
Interval -0.15 to -0.04
|
-0.12 arbitrary units
Interval -0.17 to -0.07
|
-0.07 arbitrary units
Interval -0.13 to -0.01
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in physical function, such as walking speed from baseline to post-test (90 days). The Six Minute Walk Test was used to measure data and involved participants being asked to walk as far and as fast as possible for 6-minutes on a 40m track.
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Walking Speed.
|
0.03 m/s
Interval 0.01 to 0.08
|
0.06 m/s
Interval 0.01 to 0.1
|
0.04 m/s
Interval 0.0 to 0.09
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days).
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Blood Glucose Level
|
9.49 mg/dL
Interval 2.3 to 16.67
|
0.74 mg/dL
Interval -2.02 to 3.49
|
2.94 mg/dL
Interval -2.64 to 8.51
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in levels of spontaneous physical activity from baseline to post-test (90 days). Measured using an accelerometer which is a wearable device that captures acceleration (counts) in real time, in multiple planes. Can be used to measure energy expenditure or stationary activity levels.
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Physical Activity Levels
|
167.0 Counts per minute
Standard Deviation 99.6
|
153.1 Counts per minute
Standard Deviation 69.2
|
170.9 Counts per minute
Standard Deviation 62.9
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in muscle protein levels, such as AMPK in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample.
Outcome measures
| Measure |
Vegetable Cellulose
n=13 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=13 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=11 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in AMPK Muscle Protein Levels.
|
0.42 arbitrary units
Standard Deviation 0.37
|
0.72 arbitrary units
Standard Deviation 0.43
|
1.50 arbitrary units
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in muscle protein levels, such as sirtuins (SIRT1), in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample.
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels.
|
0.03 arbitrary units
Interval -0.04 to 0.1
|
0.00 arbitrary units
Interval -0.06 to 0.07
|
0.01 arbitrary units
Interval -0.06 to 0.08
|
SECONDARY outcome
Timeframe: Baseline to 90 DaysChange in Short Physical Performance Battery (SPPB) Test Total Score on a scale of 0-12 from baseline to post-test (90 days). Lower scores indicate more mobility limitations while higher scores indicate minimal to no mobility limitations.
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Physical Performance
|
0.18 units on a scale 0-12
Interval -0.13 to 0.5
|
-0.08 units on a scale 0-12
Interval -0.39 to 0.22
|
0.06 units on a scale 0-12
Interval -0.27 to 0.38
|
SECONDARY outcome
Timeframe: Baseline to 90 daysChange in muscle protein levels, such as sirtuins (SIRT3), in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample.
Outcome measures
| Measure |
Vegetable Cellulose
n=20 Participants
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 Participants
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels.
|
0.01 arbitrary units
Interval -0.02 to 0.04
|
0.01 arbitrary units
Interval -0.02 to 0.04
|
-0.01 arbitrary units
Interval -0.04 to 0.02
|
Adverse Events
Vegetable Cellulose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Resveratrol 1000 mg/Day
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Resveratrol 1500 mg/Day
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vegetable Cellulose
n=20 participants at risk
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1000 mg/Day
n=21 participants at risk
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
Resveratrol 1500 mg/Day
n=19 participants at risk
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea, Burning in Stomach, Loose Stool, Nausea and Vomiting, Constipation,
|
25.0%
5/20 • 90 days
|
42.9%
9/21 • 90 days
|
57.9%
11/19 • 90 days
|
|
General disorders
General Issues
|
50.0%
10/20 • 90 days
|
9.5%
2/21 • 90 days
|
52.6%
10/19 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness, joint inflammation and pain, hand surgery
|
10.0%
2/20 • 90 days
|
14.3%
3/21 • 90 days
|
21.1%
4/19 • 90 days
|
|
Infections and infestations
Bronchitis, conjunctivitis, common cold, bacterial and fungal infections
|
45.0%
9/20 • 90 days
|
4.8%
1/21 • 90 days
|
47.4%
9/19 • 90 days
|
|
Renal and urinary disorders
Increased urination urge, UTI, and kidney stones
|
5.0%
1/20 • 90 days
|
14.3%
3/21 • 90 days
|
5.3%
1/19 • 90 days
|
|
Hepatobiliary disorders
Abnormal liver function values
|
0.00%
0/20 • 90 days
|
0.00%
0/21 • 90 days
|
5.3%
1/19 • 90 days
|
|
Ear and labyrinth disorders
Tinnitis in ear
|
0.00%
0/20 • 90 days
|
0.00%
0/21 • 90 days
|
5.3%
1/19 • 90 days
|
|
Blood and lymphatic system disorders
Significantly low platelet and white blood cell count
|
0.00%
0/20 • 90 days
|
0.00%
0/21 • 90 days
|
5.3%
1/19 • 90 days
|
|
General disorders
Product issue
|
0.00%
0/20 • 90 days
|
4.8%
1/21 • 90 days
|
0.00%
0/19 • 90 days
|
|
Cardiac disorders
Atrial Fibrillation and irregular heart beat
|
10.0%
2/20 • 90 days
|
0.00%
0/21 • 90 days
|
0.00%
0/19 • 90 days
|
|
Social circumstances
Snake Bite
|
0.00%
0/20 • 90 days
|
4.8%
1/21 • 90 days
|
0.00%
0/19 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place