Trial Outcomes & Findings for Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion (NCT NCT02114892)

NCT ID: NCT02114892

Last Updated: 2020-09-17

Results Overview

The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2020-09-17

Participant Flow

Participant milestones

Measure	Resveratrol Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Study STARTED	12	12
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Resveratrol Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Baseline characteristics by cohort

Measure	Resveratrol n=12 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=12 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg	Total n=24 Participants Total of all reporting groups
Age, Continuous	39.75 years STANDARD_DEVIATION 5.38 • n=5 Participants	40.33 years STANDARD_DEVIATION 5.41 • n=7 Participants	40.04 years STANDARD_DEVIATION 5.29 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Body weight	94.4 kg STANDARD_DEVIATION 13.2 • n=5 Participants	91.0 kg STANDARD_DEVIATION 10.7 • n=7 Participants	92.71 kg STANDARD_DEVIATION 11.90 • n=5 Participants
Height	162.67 cm STANDARD_DEVIATION 7.2 • n=5 Participants	164.33 cm STANDARD_DEVIATION 7.2 • n=7 Participants	163.50 cm STANDARD_DEVIATION 7.1 • n=5 Participants
Body mass index (BMI)	35.56 kg/m2 STANDARD_DEVIATION 3.2 • n=5 Participants	33.73 kg/m2 STANDARD_DEVIATION 3.7 • n=7 Participants	34.65 kg/m2 STANDARD_DEVIATION 3.5 • n=5 Participants
Fat Mass	41.18 kg STANDARD_DEVIATION 7.9 • n=5 Participants	36.13 kg STANDARD_DEVIATION 9.2 • n=7 Participants	38.66 kg STANDARD_DEVIATION 8.8 • n=5 Participants
Waist circumference	109.83 cm STANDARD_DEVIATION 9.3 • n=5 Participants	104.50 cm STANDARD_DEVIATION 8.5 • n=7 Participants	107.17 cm STANDARD_DEVIATION 9.1 • n=5 Participants
Systolic blood pressure	119.96 mmHg STANDARD_DEVIATION 13.1 • n=5 Participants	116.03 mmHg STANDARD_DEVIATION 13.2 • n=7 Participants	117.99 mmHg STANDARD_DEVIATION 13.0 • n=5 Participants
Diastolic blood pressure	78.36 mmHg STANDARD_DEVIATION 8.7 • n=5 Participants	77.15 mmHg STANDARD_DEVIATION 8.4 • n=7 Participants	77.76 mmHg STANDARD_DEVIATION 8.4 • n=5 Participants
Glucose 0'	4.8 mmol/l STANDARD_DEVIATION 0.6 • n=5 Participants	5.1 mmol/l STANDARD_DEVIATION 0.4 • n=7 Participants	4.95 mmol/l STANDARD_DEVIATION 0.5 • n=5 Participants
Glucose 30'	8.5 mmol/l STANDARD_DEVIATION 1.8 • n=5 Participants	8.4 mmol/l STANDARD_DEVIATION 1.1 • n=7 Participants	8.4 mmol/l STANDARD_DEVIATION 1.4 • n=5 Participants
Glucose 60'	9.0 mmol/l STANDARD_DEVIATION 2.7 • n=5 Participants	9.3 mmol/l STANDARD_DEVIATION 1.8 • n=7 Participants	9.1 mmol/l STANDARD_DEVIATION 2.2 • n=5 Participants
Glucose 90'	8.3 mmol/l STANDARD_DEVIATION 2.3 • n=5 Participants	8.0 mmol/l STANDARD_DEVIATION 1.8 • n=7 Participants	8.2 mmol/l STANDARD_DEVIATION 2.0 • n=5 Participants
Glucose 120'	6.5 mmol/l STANDARD_DEVIATION 1.7 • n=5 Participants	6.9 mmol/l STANDARD_DEVIATION 2.2 • n=7 Participants	6.7 mmol/l STANDARD_DEVIATION 1.9 • n=5 Participants
Cholesterol	206.0 mg/dL STANDARD_DEVIATION 32.0 • n=5 Participants	195.4 mg/dL STANDARD_DEVIATION 34.8 • n=7 Participants	200.7 mg/dL STANDARD_DEVIATION 33.1 • n=5 Participants
Triglycerides	254.3 mg/dL STANDARD_DEVIATION 55.6 • n=5 Participants	233.8 mg/dL STANDARD_DEVIATION 77.7 • n=7 Participants	244.0 mg/dL STANDARD_DEVIATION 66.9 • n=5 Participants
HDL-c	37.3 mg/dL STANDARD_DEVIATION 3.7 • n=5 Participants	37.9 mg/dL STANDARD_DEVIATION 7.7 • n=7 Participants	37.6 mg/dL STANDARD_DEVIATION 5.9 • n=5 Participants
LDL-c	120.7 mg/dL STANDARD_DEVIATION 32.0 • n=5 Participants	119.8 mg/dL STANDARD_DEVIATION 46.5 • n=7 Participants	120.2 mg/dL STANDARD_DEVIATION 39.0 • n=5 Participants
AUC glucose	935.8 mmol*h/L STANDARD_DEVIATION 188.6 • n=5 Participants	950.8 mmol*h/L STANDARD_DEVIATION 167.6 • n=7 Participants	943.3 mmol*h/L STANDARD_DEVIATION 174.6 • n=5 Participants
AUC insuline	48418.5 pmol*h/L STANDARD_DEVIATION 22707.4 • n=5 Participants	62955.8 pmol*h/L STANDARD_DEVIATION 37620.0 • n=7 Participants	55687.1 pmol*h/L STANDARD_DEVIATION 31282.6 • n=5 Participants
Total insulin secretion	0.48 index STANDARD_DEVIATION 0.22 • n=5 Participants	0.59 index STANDARD_DEVIATION 0.29 • n=7 Participants	0.54 index STANDARD_DEVIATION 0.26 • n=5 Participants
First phase of insulin secretion	1256.6 index STANDARD_DEVIATION 601.5 • n=5 Participants	1440.0 index STANDARD_DEVIATION 619.8 • n=7 Participants	1348.3 index STANDARD_DEVIATION 604.6 • n=5 Participants
Insulin sensitivity	3.5 index STANDARD_DEVIATION 1.5 • n=5 Participants	3.3 index STANDARD_DEVIATION 1.5 • n=7 Participants	3.4 index STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Triglycerides Levels at Week 12	210.6 mg/dL Standard Deviation 63.3	235.8 mg/dL Standard Deviation 148.5

PRIMARY outcome

Timeframe: Baseline. Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
High Density Lipoprotein (c-HDL) Levels at Week 12.	37.6 mg/dL Standard Deviation 5.0	41.1 mg/dL Standard Deviation 8.8

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Fasting Glucose Levels at Week 12.	4.6 mmol/L Standard Deviation 0.6	4.5 mmol/L Standard Deviation 0.5

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Systolic Blood Pressure at Week 12.	116.1 mmHg Standard Deviation 11.3	121.7 mmHg Standard Deviation 11.0

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
First Phase of Insulin Secretion at Week 12.	1019.7 index Standard Deviation 335.1	1279.3 index Standard Deviation 599.2

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Total Insulin Secretion at Week 12.	.28 index Standard Deviation 0.08	.60 index Standard Deviation 0.30

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Total Insulin Sensitivity at Week 12.	4.2 index Standard Deviation 1.2	4.7 index Standard Deviation 2.4

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Waist Circumference at Week 12	105.4 cm Standard Deviation 10.7	105.8 cm Standard Deviation 7.2

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Diastolic Blood Pressure at Week 12	78.1 mmHg Standard Deviation 9.2	78.9 mmHg Standard Deviation 7.5

SECONDARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Weight at Week 12.	90.5 kg Standard Deviation 12.3	93.1 kg Standard Deviation 9.1

SECONDARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Body Mass Index at Week 12	34.3 kg/m2 Standard Deviation 3.0	34.0 kg/m2 Standard Deviation 3.6

SECONDARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Total Cholesterol at Week 12	203.4 mg/dL Standard Deviation 38.0	208.9 mg/dL Standard Deviation 27.1

SECONDARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Low Density Lipoproteins (c-LDL) at Week 12	122.3 mg/dL Standard Deviation 39.2	126.8 mg/dL Standard Deviation 33.7

SECONDARY outcome

Timeframe: Baseline. Week 12.

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Creatinine at Week 12.	57.94 µmol/l Standard Deviation 14.20	63.29 µmol/l Standard Deviation 11.07

SECONDARY outcome

Timeframe: Week 12.

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12

Outcome measures

Measure	Resveratrol n=11 Participants Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=10 Participants Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Uric Acid at Week 12.	277.93 µmol/l Standard Deviation 38.72	364.03 µmol/l Standard Deviation 67.95

Adverse Events

Resveratrol

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Resveratrol n=12 participants at risk Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Placebo n=12 participants at risk Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Nervous system disorders Headache	25.0% 3/12 • Number of events 3 • Adverse events were collected throughout the study	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study
Gastrointestinal disorders Sickness	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study	0.00% 0/12 • Adverse events were collected throughout the study
Blood and lymphatic system disorders Nosebleed	0.00% 0/12 • Adverse events were collected throughout the study	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study
Gastrointestinal disorders Constipation	0.00% 0/12 • Adverse events were collected throughout the study	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study
Gastrointestinal disorders Flatulence	0.00% 0/12 • Adverse events were collected throughout the study	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the study

Additional Information

Dr. Manuel González Ortiz

Institute of Experimental andl Clinical Therapeutics

Phone: +52-33-10-58-52-00

Email: uiec@prodigy.net.mx

Results disclosure agreements

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