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Trial record 3 of 134 for:    SRT501 AND Platelet Aggregation

Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years

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ClinicalTrials.gov Identifier: NCT01668836
Recruitment Status : Completed
First Posted : August 20, 2012
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
ANTONIO DE PADUA MANSUR, InCor Heart Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Vascular System Injuries
Lipid Metabolism Disorders
Endothelial Disfunction
Interventions Drug: Resveratrol
Behavioral: Caloric restriction
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

Period Title: Overall Study
Started 12 12 12 12
Completed 12 12 12 12
Not Completed 0 0 0 0
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction Total
Hide Arm/Group Description

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
58.4  (3.6) 58.5  (3.4) 57.7  (3.5) 59.5  (3.7) 58.5  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
Female
0
   0.0%
12
 100.0%
0
   0.0%
12
 100.0%
24
  50.0%
Male
12
 100.0%
0
   0.0%
12
 100.0%
0
   0.0%
24
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
12 12 12 12 48
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
28.5  (4.4) 26.5  (3.4) 26.2  (3.5) 25.5  (3.7) 26.7  (3.8)
abdominal circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
100.9  (13.9) 92.7  (8.7) 96.5  (7.6) 92  (7) 95.5  (10)
heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
63.6  (7.9) 65.6  (9.1) 63.9  (10.7) 60.8  (8.3) 63.6  (9.0)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
136.9  (15.0) 126  (14.5) 133.2  (16.6) 125.6  (14.1) 130.6  (15.4)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
83.9  (12.0) 78.5  (9.3) 84.8  (9.9) 80.6  (12.3) 82  (10.8)
total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
192.8  (28.1) 222.7  (32.5) 197.3  (36.2) 235.1  (44.9) 212.0  (39.1)
HDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
43.6  (10.2) 54.8  (15.2) 43.5  (9.0) 67.2  (18.2) 52.3  (16.5)
LDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
125.5  (29.9) 140.8  (28.7) 127.6  (34.0) 149.8  (37.6) 135.5  (32.0)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
126.5  (63.0) 121.6  (72.4) 131.0  (77.9) 91.4  (37.4) 117.6  (64.4)
C-reactive protein  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
1.13  (0.67) 3.47  (2.38) 1.63  (1.01) 2.31  (2.44) 2.13  (1.92)
Apolipoprotein A1  
Mean (Standard Deviation)
Unit of measure:  g/L
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
1.37  (0.21) 1.53  (0.19) 1.34  (0.11) 1.72  (0.25) 1.49  (0.24)
Apolipoprotein B  
Mean (Standard Deviation)
Unit of measure:  g/L
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
0.91  (0.18) 1.04  (0.28) 0.97  (0.25) 1.04  (0.27) 0.99  (0.25)
lipoprotein (a)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
16.2  (20.1) 24.1  (29.7) 31.8  (44.7) 23.9  (17.4) 24.0  (29.5)
glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
95.8  (14.1) 96.3  (13.8) 91.8  (12.6) 95.4  (8.5) 94.8  (12.2)
luteinizing hormone  
Mean (Standard Deviation)
Unit of measure:  microUI/mL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
3.34  (1.67) 20.9  (7.53) 4.46  (1.95) 29.9  (9.05) 14.7  (12.7)
follicle stimulating hormone  
Mean (Standard Deviation)
Unit of measure:  microUI/mL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
4.12  (2.2) 60.8  (20.4) 6.22  (3.53) 75.8  (18.7) 36.8  (35.1)
Estradiol  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
36.4  (10.5) 38.6  (16.4) 43.4  (12.3) 25.9  (8.3) 36.0  (13.5)
norepinephrine  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
267.8  (148.9) 270.8  (88.6) 286.3  (126.8) 420.9  (171.0) 306.7  (144.5)
Insulin  
Mean (Standard Deviation)
Unit of measure:  microUI/L
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
53.7  (33.7) 77.1  (62.2) 69.3  (57.1) 44.3  (28.9) 61.5  (48.2)
Sirtuin  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
0.95  (0.46) 1.16  (0.90) 1.65  (1.40) 1.65  (2.21) 1.35  (1.39)
Estrone  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
17.6  (18.3) 12.4  (17.4) 3.1  (0.0) 5.11  (6.7) 10.0  (14.7)
Sirtuin-1 gene expression by real time polimerase chain reaction "RT-PCR"   [1] 
Mean (Standard Deviation)
Unit of measure:  Arbitrary unit
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
10.4  (1.28) 11.6  (1.38) 11.4  (1.26) 10.6  (1.15) 11.0  (1.33)
[1]
Measure Description: Values obtained from delta CT (cycle threshold) using as normalizer GAPDH gene.
RAGE (receptor for advanced glycation end-products) gene expression "RT-PCR"  
Mean (Standard Deviation)
Unit of measure:  Arbitrary unit
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
11.3  (1.24) 12.7  (1.65) 10.9  (1.68) 10.5  (1.76) 11.3  (1.74)
Platelet aggregation by adenosine diphosphate (ADP)   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
86.13  (4.06) 88.90  (5.87) 84.20  (7.80) 88.45  (3.65) 86.92  (5.74)
[1]
Measure Description: percentage of maximum amplitude aggregation by adenosine diphosphate
Platelet aggregation by epinephrine   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
84.23  (3.90) 83.42  (10.22) 66.88  (25.92) 81.20  (18.27) 78.93  (17.72)
[1]
Measure Description: percentage of maximum amplitude aggregation
Nonesterified fatty acid  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
25.73  (16.55) 18.64  (14.12) 29.75  (49.34) 24.17  (20.92) 24.67  (28.69)
Clot onset time  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
38.25  (4.16) 30.75  (9.58) 38.25  (4.00) 91.64  (177.95) 48.83  (86.58)
Clot complete  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
103.83  (13.67) 80.83  (12.01) 100.17  (14.32) 152.64  (211.01) 108.45  (102.45)
Slope   [1] 
Mean (Standard Deviation)
Unit of measure:  Pascal/min
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
100.83  (38.42) 165.42  (60.43) 108.17  (43.98) 158.36  (37.85) 132.66  (53.47)
[1]
Measure Description: Slope reflects activity of fibrinogen and platelet function. Denotes the speed at which solid clot was formed. Its value is reduced in presence of low levels of fibrinogen and platelet function. It shows the strength which the clot is formed.
Max Elasticity  
Mean (Standard Deviation)
Unit of measure:  Pascal
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
1598.50  (398.18) 2202.98  (391.50) 1639.82  (383.97) 2164.64  (275.91) 1895.88  (456.53)
1.Primary Outcome
Title Direct Evaluation of the Sirtuin 1 Gene Expression
Hide Description The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. "Arbitrary unit was relative to the control gene expression (control gene = 1)".
Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: arbitrary unit relative to control gene
11.04  (1.75) 11.43  (1.42) 12.84  (1.36) 12.05  (1.13)
2.Primary Outcome
Title Sirtuin
Hide Description Sirtuin plasma levels before and 30 days post-treatment
Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
4.84  (2.78) 6.67  (2.99) 6.14  (1.98) 5.46  (2.51)
3.Secondary Outcome
Title Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "mg/dL"
HDL-cholesterol "mg/dL" 43.00  (10.37) 53.33  (15.11) 41.08  (9.10) 62.92  (15.16)
LDL-cholesterol "mg/dL" 125.50  (29.93) 153.58  (45.92) 126.33  (33.47) 134.25  (34.27)
Lipoprotein(a)"mg/dL" 15.03  (19.98) 24.43  (33.57) 32.73  (41.34) 20.86  (12.82)
total cholesterol "mg/dL" 196.08  (31.67) 239.08  (47.12) 193.83  (37.20) 211.50  (41.79)
Triglycerides "mg/dL" 137.75  (62.22) 159.50  (118.13) 131.00  (77.91) 72.25  (30.58)
C-reactive protein "mg/dL" 0.13  (0.14) 0.28  (0.23) 0.17  (0.14) 0.16  (0.11)
glucose "mg/dL" 99.83  (16.29) 97.33  (12.51) 89.92  (5.78) 91.17  (6.19)
4.Secondary Outcome
Title Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- apolipoproteins AI and B

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:
12 men will receive a pill with 500mg of resveratrol
12 women will receive a pill with 500mg of resveratrol
12 men will follow a 1000Kcal/day of caloric restriction
12 women will follow a 1000Kcal/day of caloric restriction
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "g/dL"
Apolipoprotein A1 "g/dL" 1.33  (0.20) 1.55  (0.24) 1.29  (0.21) 1.57  (0.29)
Apolipoprotein B "g/dL" 0.95  (0.19) 1.13  (0.31) 0.97  (0.27) 0.93  (0.26)
5.Secondary Outcome
Title Influence of the Sirtuin 1 System on Estradiol
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- estradiol

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "pg/mL"
38.92  (13.60) 34.81  (12.73) 42.13  (14.26) 29.05  (7.67)
6.Secondary Outcome
Title Influence of the Sirtuin 1 System on Platelet Aggregation.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- platelet aggregation by ADP and norepinephrine.

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: percentage platelet aggregation
Platelet aggregation by ADP "%" 88.03  (4.92) 88.96  (4.15) 87.32  (4.12) 87.24  (12.06)
Platelet aggregation by norepinephrine "%" 81.06  (10.46) 81.77  (16.91) 74.43  (23.83) 72.09  (27.37)
7.Secondary Outcome
Title Influence of the Sirtuin 1 System on Biomarkers
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "microUI/mL"
Non sterified fatty acid "microUI/mL" 22.45  (10.32) 23.73  (12.51) 8.83  (8.73) 24.67  (19.43)
Insulin "microUI/mL" 79.00  (54.55) 80.58  (64.15) 53.25  (32.28) 67.08  (30.20)
Luteinizing hormone "microUI/mL" 3.93  (1.66) 19.97  (7.01) 4.50  (1.65) 28.56  (11.77)
Follicle stimulating hormone "microUI/mL" 4.40  (2.26) 57.78  (15.35) 6.31  (3.71) 79.79  (26.04)
8.Secondary Outcome
Title Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- estrone, norepinephrine.

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "pg/dL"
Norepinephrine "pg/dL" 219.33  (99.24) 227.83  (92.13) 190.83  (124.82) 329.00  (194.11)
Estrone"pg/dL" 14.92  (18.54) 13.23  (15.49) 7.62  (15.68) 4.12  (3.52)
9.Secondary Outcome
Title Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

  • RAGE gene expression
  • "Arbitrary unit was relative to the control gene expression (control gene = 1)"
Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: arbitrary unit relative to control gene
11.88  (1.80) 12.78  (1.38) 12.17  (1.99) 11.75  (1.74)
10.Secondary Outcome
Title Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

-dynamics of clot formation: clot onset time and clot complet

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "sec"
Clot onset time "sec" 38.00  (5.62) 35.50  (5.50) 40.42  (7.93) 35.67  (5.82)
Clot complet "sec" 100.83  (17.47) 89.00  (16.59) 101.00  (23.68) 86.83  (15.75)
11.Secondary Outcome
Title Influence of the Sirtuin 1 System on Thromboelastography.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

- slope of clot formation dynamics

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "Pascal/min"
106.83  (50.13) 158.67  (47.13) 115.42  (67.38) 156.75  (43.42)
12.Secondary Outcome
Title Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.
Hide Description

For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

-max elasticity of clot on thromboelastography

Time Frame 30 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days

12 men will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

12 women will follow a 1000kcal/day diet for 30 days

Caloric restriction: Diet of 1,000kcal per day for 30 days

Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: "Pascal"
1690.58  (522.54) 2059.83  (337.48) 1691.50  (380.49) 2041.12  (318.71)
13.Other Pre-specified Outcome
Title Differences Between Men and Women.
Hide Description We will also compare women vs men baseline and final data.
Time Frame 30 days
Outcome Measure Data Not Reported
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Hide Arm/Group Description 12 men will receive a pill with 500mg of resveratrol 12 women will receive a pill with 500mg of resveratrol 12 men will follow a 1000Kcal/day of caloric restriction 12 women will follow a 1000Kcal/day of caloric restriction
All-Cause Mortality
Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Men With Resveratrol Women With Resveratrol Men With Caloric Restriction Women With Caloric Restriction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Antonio de Padua Mansur - Associate Professor
Organization: Heart Institute (InCor), University of São Paulo Medical School
Phone: 55-11-26615387
Responsible Party: ANTONIO DE PADUA MANSUR, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT01668836     History of Changes
Other Study ID Numbers: 788012
2012/01051-5 ( Other Grant/Funding Number: FAPESP - SAO PAULO RESEARCH FOUNDATION )
First Submitted: August 14, 2012
First Posted: August 20, 2012
Results First Submitted: August 24, 2015
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016