Trial Outcomes & Findings for Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans (NCT NCT01354977)

NCT ID: NCT01354977

Last Updated: 2022-03-08

Results Overview

We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD). RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2022-03-08

Participant Flow

Participant milestones

Measure	Resveratrol Each participant received resveratrol, 1,000mg twice daily for 28 days in a randomized, double blinded placebo-controlled fashion. The investigators used a research procedure called a "pancreatic clamp" study to study the effects of Resveratrol. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.	Placebo Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days in a randomized, double blinded placebo-controlled fashion. The investigators used a research procedure called a "pancreatic clamp" study to study the effects of Resveratrol. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
Overall Study STARTED	12	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

Baseline characteristics by cohort

Measure	Resveratrol n=12 Participants Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days	Placebo n=8 Participants Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days	Total n=20 Participants Total of all reporting groups
Age, Continuous	50.75 years STANDARD_DEVIATION 10.50 • n=5 Participants	52.88 years STANDARD_DEVIATION 5.44 • n=7 Participants	51.6 years STANDARD_DEVIATION 8.71 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD).

RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).

Outcome measures

Measure	Resveratrol n=12 Participants Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.	Placebo n=8 Participants Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks. RD at baseline	6.573 mg/kg/min Standard Deviation 1.709	7.272 mg/kg/min Standard Deviation 2.810
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks. RD at 4 weeks	8.445 mg/kg/min Standard Deviation 3.616	7.419 mg/kg/min Standard Deviation 2.785

SECONDARY outcome

Timeframe: 4 weeks

Endogenous glucose production will be used to determine hepatic insulin sensitivity.

Rates of EGP (a measure of the body's production of sugar) will be measured using a 6 hour stepped pancreatic clamp procedure under various treatment conditions (eg, resveratrol or placebo), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).

Outcome measures

Measure	Resveratrol n=12 Participants Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.	Placebo n=8 Participants Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks. EGP at baseline	1.014 mg/kg/min Standard Deviation 0.353	0.903 mg/kg/min Standard Deviation 0.436
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks. EGP at 4 weeks	1.140 mg/kg/min Standard Deviation 0.525	1.552 mg/kg/min Standard Deviation 0.962

SECONDARY outcome

Timeframe: 4 weeks

Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.

Outcome measures

Measure	Resveratrol n=12 Participants Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.	Placebo n=8 Participants Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers 4 weeks_mitochondria number	46.622 mitochondria number Standard Deviation 18.895	48.850 mitochondria number Standard Deviation 14.632
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers Baseline_mitochondria number	48.489 mitochondria number Standard Deviation 13.180	41.275 mitochondria number Standard Deviation 10.826

SECONDARY outcome

Timeframe: 4 weeks

Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo

Outcome measures

Measure	Resveratrol n=12 Participants Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.	Placebo n=8 Participants Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks TNFa_Whole adipose tissue	0.47 Ratio Standard Deviation 0.21	1.4 Ratio Standard Deviation 0.82
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks IL6_Whole adipose tissue	1.84 Ratio Standard Deviation 3.59	1.68 Ratio Standard Deviation 1.3
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks PAI-1_Whole adipose tissue	0.56 Ratio Standard Deviation 0.16	0.76 Ratio Standard Deviation 0.25

SECONDARY outcome

Timeframe: 4 Weeks

Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment

Outcome measures

Measure	Resveratrol n=12 Participants Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.	Placebo n=8 Participants Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
Muscle Mitochondrial Area Baseline_mitochondria area	0.070 µm² Standard Deviation 0.021	0.080 µm² Standard Deviation 0.026
Muscle Mitochondrial Area 4 weeks_mitochondria area	0.098 µm² Standard Deviation 0.039	0.102 µm² Standard Deviation 0.020

Adverse Events

Resveratrol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Resveratrol n=12 participants at risk Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.	Placebo n=8 participants at risk Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
Gastrointestinal disorders Nausea and vomiting	8.3% 1/12 • Number of events 1 • Through study completion, an average of 4 weeks. Not reported	0.00% 0/8 • Through study completion, an average of 4 weeks. Not reported
Gastrointestinal disorders Diaphoresis, nausea and lightheadedness	8.3% 1/12 • Number of events 1 • Through study completion, an average of 4 weeks. Not reported	0.00% 0/8 • Through study completion, an average of 4 weeks. Not reported
Nervous system disorders Vasovagal reflex	8.3% 1/12 • Number of events 1 • Through study completion, an average of 4 weeks. Not reported	0.00% 0/8 • Through study completion, an average of 4 weeks. Not reported

Additional Information

Dr. Meredith Hawkins

Albert Einstein College of Medicine

Phone: 7184302903

Email: meredith.hawkins@einstein.yu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place