Trial Outcomes & Findings for Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance (NCT NCT01375959)
NCT ID: NCT01375959
Last Updated: 2022-10-26
Results Overview
Glucose AUC following a standard mixed meal challenge AUC, Area Under a Curve. There are no "normal ranges" but a higher value is worse than a lower value.
COMPLETED
NA
38 participants
end of each of two 6 week treatment periods
2022-10-26
Participant Flow
Participant milestones
| Measure |
Resveratrol First, Then Placebo
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
wash-out period for 2 weeks
matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
|
Placebo First, Then Resveratrol
matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
wash-out period for 2 weeks
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
17
|
21
|
|
First Intervention (6 Weeks)
Received Invertention
|
17
|
21
|
|
First Intervention (6 Weeks)
COMPLETED
|
15
|
18
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
2
|
3
|
|
Wash-Out (3 Weeks)
STARTED
|
15
|
18
|
|
Wash-Out (3 Weeks)
COMPLETED
|
15
|
18
|
|
Wash-Out (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
15
|
18
|
|
Second Intervention (6 Weeks)
COMPLETED
|
15
|
15
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Resveratrol First, Then Placebo
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
wash-out period for 2 weeks
matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
|
Placebo First, Then Resveratrol
matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
wash-out period for 2 weeks
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
|
|---|---|---|
|
First Intervention (6 Weeks)
Adverse Event
|
2
|
3
|
|
Second Intervention (6 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention (6 Weeks)
Adverse Event
|
0
|
2
|
Baseline Characteristics
Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance
Baseline characteristics by cohort
| Measure |
Resveratrol First
n=17 Participants
resveratrol 500 mg capsules, 3 each day for 6 weeks
resveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
|
Placebo First
n=21 Participants
matching placebo capsule containing lactose, 3 each day for 6 weeks
Placebo: 3 placebo capsules orally twice a day for 6 weeks
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 8 • n=5 Participants
|
67 years
STANDARD_DEVIATION 6 • n=7 Participants
|
67 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of each of two 6 week treatment periodsPopulation: Out of 38 total randomized, 35 actually received resveratrol and 36 actually received placebo.
Glucose AUC following a standard mixed meal challenge AUC, Area Under a Curve. There are no "normal ranges" but a higher value is worse than a lower value.
Outcome measures
| Measure |
Resveratrol
n=35 Participants
Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.
|
Placebo
n=36 Participants
Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.
|
|---|---|---|
|
Post Meal Glucose Area Under the Curve
|
508 mg*hr/dL
Standard Deviation 88
|
513 mg*hr/dL
Standard Deviation 80
|
SECONDARY outcome
Timeframe: end of each of two 6 week treatment periodsInsulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting plasma glucose X fasting plasma insulin) (mean plasma glucose X mean plasma insulin)}. This is a unitless measure. The Matsuda index is considered an early biomarker for metabolic dysregulation and is an effective clinical tool to define insulin sensitivity (i.e., the ability of tissues to respond to the signal of insulin) and secretory defects in individuals with impaired glucose homeostasis. The Matsuda index correlates strongly with the euglycemic insulin clamp which is a direct measure of insulin sensitivity. In the United States, it is recognized that participants who do not have insulin resistance have Matsuda Index values of \>=2.5.
Outcome measures
| Measure |
Resveratrol
n=30 Participants
Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.
|
Placebo
n=30 Participants
Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.
|
|---|---|---|
|
Insulin Sensitivity Using a Modification of the Matsuda Index
|
2.3 units on a scale
Standard Deviation 1.7
|
2.0 units on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: end of each of two 6 week treatment periodsc-peptide deconvolution; HOMA-B
Outcome measures
| Measure |
Resveratrol
n=30 Participants
Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.
|
Placebo
n=30 Participants
Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.
|
|---|---|---|
|
Insulin Secretion
|
8.9 pmol/kg/min
Standard Deviation 3.0
|
8.1 pmol/kg/min
Standard Deviation 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: end of each of two 6 week treatment periodsReactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) index is the ratio of the average pulse amplitude in the posthyperemic phase divided by the average baseline amplitude, with normalization to the signal in the control arm to compensate for any systemic changes. RH-PAT is a non-invasive and user-independent technique used to assess peripheral microvascular endothelial function by measuring changes in digital pulse volume during reactive hyperemia. Lower RH-PAT scores are associated with flow mediated dilatation (FMD) and may predict mortality in subjects with cardiovascular (CV) risk factors including obesity, total/HDL cholesterol ratio, diabetes, smoking and dyslipidemia.
Outcome measures
| Measure |
Resveratrol
n=30 Participants
Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.
|
Placebo
n=30 Participants
Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.
|
|---|---|---|
|
Peripheral Microvascular Endothelial Function Via Reactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) Index
|
2.02 RH-PAT Index
Standard Deviation 0.2
|
1.76 RH-PAT Index
Standard Deviation 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: end of each of two 6 week treatment periodsGene expression in skeletal muscle using RNASeq
Outcome measures
| Measure |
Resveratrol
n=30 Participants
Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.
|
Placebo
n=30 Participants
Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.
|
|---|---|---|
|
Number of Differentially Expressed Transcripts
|
140 differentially expressed transcripts
|
0 differentially expressed transcripts
|
Adverse Events
Resveratrol
Placebo
Serious adverse events
| Measure |
Resveratrol
n=38 participants at risk
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
|
Placebo
n=38 participants at risk
matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
|
|---|---|---|
|
Infections and infestations
pneumonia
|
0.00%
0/38 • During full 16 week study period
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
Other adverse events
| Measure |
Resveratrol
n=38 participants at risk
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
|
Placebo
n=38 participants at risk
matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
5.3%
2/38 • Number of events 2 • During full 16 week study period
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
|
Gastrointestinal disorders
diarrhea
|
5.3%
2/38 • Number of events 2 • During full 16 week study period
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
|
Gastrointestinal disorders
abdominal pain
|
5.3%
2/38 • Number of events 2 • During full 16 week study period
|
5.3%
2/38 • Number of events 2 • During full 16 week study period
|
|
Hepatobiliary disorders
abnormal liver function
|
0.00%
0/38 • During full 16 week study period
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
|
Cardiac disorders
abnormal electrocardiogram
|
0.00%
0/38 • During full 16 week study period
|
5.3%
2/38 • Number of events 2 • During full 16 week study period
|
|
Renal and urinary disorders
elevated PSA
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
0.00%
0/38 • During full 16 week study period
|
|
Metabolism and nutrition disorders
gout
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
0.00%
0/38 • During full 16 week study period
|
|
General disorders
weight loss
|
0.00%
0/38 • During full 16 week study period
|
2.6%
1/38 • Number of events 1 • During full 16 week study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place