Trial Outcomes & Findings for Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years (NCT NCT01668836)
NCT ID: NCT01668836
Last Updated: 2016-04-18
Results Overview
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)".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
30 days post-treatment
Results posted on
2016-04-18
Participant Flow
Participant milestones
| Measure |
Men With Resveratrol
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
|
Women With Resveratrol
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
|
Men With Caloric Restriction
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
Baseline characteristics by cohort
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 3.7 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 3.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Body mass index
|
28.5 Kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
26.5 Kg/m^2
STANDARD_DEVIATION 3.4 • n=7 Participants
|
26.2 Kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
25.5 Kg/m^2
STANDARD_DEVIATION 3.7 • n=4 Participants
|
26.7 Kg/m^2
STANDARD_DEVIATION 3.8 • n=21 Participants
|
|
abdominal circumference
|
100.9 cm
STANDARD_DEVIATION 13.9 • n=5 Participants
|
92.7 cm
STANDARD_DEVIATION 8.7 • n=7 Participants
|
96.5 cm
STANDARD_DEVIATION 7.6 • n=5 Participants
|
92 cm
STANDARD_DEVIATION 7 • n=4 Participants
|
95.5 cm
STANDARD_DEVIATION 10 • n=21 Participants
|
|
heart rate
|
63.6 beats/minute
STANDARD_DEVIATION 7.9 • n=5 Participants
|
65.6 beats/minute
STANDARD_DEVIATION 9.1 • n=7 Participants
|
63.9 beats/minute
STANDARD_DEVIATION 10.7 • n=5 Participants
|
60.8 beats/minute
STANDARD_DEVIATION 8.3 • n=4 Participants
|
63.6 beats/minute
STANDARD_DEVIATION 9.0 • n=21 Participants
|
|
Systolic blood pressure
|
136.9 mmHg
STANDARD_DEVIATION 15.0 • n=5 Participants
|
126 mmHg
STANDARD_DEVIATION 14.5 • n=7 Participants
|
133.2 mmHg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
125.6 mmHg
STANDARD_DEVIATION 14.1 • n=4 Participants
|
130.6 mmHg
STANDARD_DEVIATION 15.4 • n=21 Participants
|
|
Diastolic blood pressure
|
83.9 mmHg
STANDARD_DEVIATION 12.0 • n=5 Participants
|
78.5 mmHg
STANDARD_DEVIATION 9.3 • n=7 Participants
|
84.8 mmHg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
80.6 mmHg
STANDARD_DEVIATION 12.3 • n=4 Participants
|
82 mmHg
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
total cholesterol
|
192.8 mg/dL
STANDARD_DEVIATION 28.1 • n=5 Participants
|
222.7 mg/dL
STANDARD_DEVIATION 32.5 • n=7 Participants
|
197.3 mg/dL
STANDARD_DEVIATION 36.2 • n=5 Participants
|
235.1 mg/dL
STANDARD_DEVIATION 44.9 • n=4 Participants
|
212.0 mg/dL
STANDARD_DEVIATION 39.1 • n=21 Participants
|
|
HDL-cholesterol
|
43.6 mg/dL
STANDARD_DEVIATION 10.2 • n=5 Participants
|
54.8 mg/dL
STANDARD_DEVIATION 15.2 • n=7 Participants
|
43.5 mg/dL
STANDARD_DEVIATION 9.0 • n=5 Participants
|
67.2 mg/dL
STANDARD_DEVIATION 18.2 • n=4 Participants
|
52.3 mg/dL
STANDARD_DEVIATION 16.5 • n=21 Participants
|
|
LDL-cholesterol
|
125.5 mg/dL
STANDARD_DEVIATION 29.9 • n=5 Participants
|
140.8 mg/dL
STANDARD_DEVIATION 28.7 • n=7 Participants
|
127.6 mg/dL
STANDARD_DEVIATION 34.0 • n=5 Participants
|
149.8 mg/dL
STANDARD_DEVIATION 37.6 • n=4 Participants
|
135.5 mg/dL
STANDARD_DEVIATION 32.0 • n=21 Participants
|
|
Triglycerides
|
126.5 mg/dL
STANDARD_DEVIATION 63.0 • n=5 Participants
|
121.6 mg/dL
STANDARD_DEVIATION 72.4 • n=7 Participants
|
131.0 mg/dL
STANDARD_DEVIATION 77.9 • n=5 Participants
|
91.4 mg/dL
STANDARD_DEVIATION 37.4 • n=4 Participants
|
117.6 mg/dL
STANDARD_DEVIATION 64.4 • n=21 Participants
|
|
C-reactive protein
|
1.13 mg/dL
STANDARD_DEVIATION 0.67 • n=5 Participants
|
3.47 mg/dL
STANDARD_DEVIATION 2.38 • n=7 Participants
|
1.63 mg/dL
STANDARD_DEVIATION 1.01 • n=5 Participants
|
2.31 mg/dL
STANDARD_DEVIATION 2.44 • n=4 Participants
|
2.13 mg/dL
STANDARD_DEVIATION 1.92 • n=21 Participants
|
|
Apolipoprotein A1
|
1.37 g/L
STANDARD_DEVIATION 0.21 • n=5 Participants
|
1.53 g/L
STANDARD_DEVIATION 0.19 • n=7 Participants
|
1.34 g/L
STANDARD_DEVIATION 0.11 • n=5 Participants
|
1.72 g/L
STANDARD_DEVIATION 0.25 • n=4 Participants
|
1.49 g/L
STANDARD_DEVIATION 0.24 • n=21 Participants
|
|
Apolipoprotein B
|
0.91 g/L
STANDARD_DEVIATION 0.18 • n=5 Participants
|
1.04 g/L
STANDARD_DEVIATION 0.28 • n=7 Participants
|
0.97 g/L
STANDARD_DEVIATION 0.25 • n=5 Participants
|
1.04 g/L
STANDARD_DEVIATION 0.27 • n=4 Participants
|
0.99 g/L
STANDARD_DEVIATION 0.25 • n=21 Participants
|
|
lipoprotein (a)
|
16.2 mg/dL
STANDARD_DEVIATION 20.1 • n=5 Participants
|
24.1 mg/dL
STANDARD_DEVIATION 29.7 • n=7 Participants
|
31.8 mg/dL
STANDARD_DEVIATION 44.7 • n=5 Participants
|
23.9 mg/dL
STANDARD_DEVIATION 17.4 • n=4 Participants
|
24.0 mg/dL
STANDARD_DEVIATION 29.5 • n=21 Participants
|
|
glucose
|
95.8 mg/dL
STANDARD_DEVIATION 14.1 • n=5 Participants
|
96.3 mg/dL
STANDARD_DEVIATION 13.8 • n=7 Participants
|
91.8 mg/dL
STANDARD_DEVIATION 12.6 • n=5 Participants
|
95.4 mg/dL
STANDARD_DEVIATION 8.5 • n=4 Participants
|
94.8 mg/dL
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
luteinizing hormone
|
3.34 microUI/mL
STANDARD_DEVIATION 1.67 • n=5 Participants
|
20.9 microUI/mL
STANDARD_DEVIATION 7.53 • n=7 Participants
|
4.46 microUI/mL
STANDARD_DEVIATION 1.95 • n=5 Participants
|
29.9 microUI/mL
STANDARD_DEVIATION 9.05 • n=4 Participants
|
14.7 microUI/mL
STANDARD_DEVIATION 12.7 • n=21 Participants
|
|
follicle stimulating hormone
|
4.12 microUI/mL
STANDARD_DEVIATION 2.2 • n=5 Participants
|
60.8 microUI/mL
STANDARD_DEVIATION 20.4 • n=7 Participants
|
6.22 microUI/mL
STANDARD_DEVIATION 3.53 • n=5 Participants
|
75.8 microUI/mL
STANDARD_DEVIATION 18.7 • n=4 Participants
|
36.8 microUI/mL
STANDARD_DEVIATION 35.1 • n=21 Participants
|
|
Estradiol
|
36.4 pg/mL
STANDARD_DEVIATION 10.5 • n=5 Participants
|
38.6 pg/mL
STANDARD_DEVIATION 16.4 • n=7 Participants
|
43.4 pg/mL
STANDARD_DEVIATION 12.3 • n=5 Participants
|
25.9 pg/mL
STANDARD_DEVIATION 8.3 • n=4 Participants
|
36.0 pg/mL
STANDARD_DEVIATION 13.5 • n=21 Participants
|
|
norepinephrine
|
267.8 pg/mL
STANDARD_DEVIATION 148.9 • n=5 Participants
|
270.8 pg/mL
STANDARD_DEVIATION 88.6 • n=7 Participants
|
286.3 pg/mL
STANDARD_DEVIATION 126.8 • n=5 Participants
|
420.9 pg/mL
STANDARD_DEVIATION 171.0 • n=4 Participants
|
306.7 pg/mL
STANDARD_DEVIATION 144.5 • n=21 Participants
|
|
Insulin
|
53.7 microUI/L
STANDARD_DEVIATION 33.7 • n=5 Participants
|
77.1 microUI/L
STANDARD_DEVIATION 62.2 • n=7 Participants
|
69.3 microUI/L
STANDARD_DEVIATION 57.1 • n=5 Participants
|
44.3 microUI/L
STANDARD_DEVIATION 28.9 • n=4 Participants
|
61.5 microUI/L
STANDARD_DEVIATION 48.2 • n=21 Participants
|
|
Sirtuin
|
0.95 ng/mL
STANDARD_DEVIATION 0.46 • n=5 Participants
|
1.16 ng/mL
STANDARD_DEVIATION 0.90 • n=7 Participants
|
1.65 ng/mL
STANDARD_DEVIATION 1.40 • n=5 Participants
|
1.65 ng/mL
STANDARD_DEVIATION 2.21 • n=4 Participants
|
1.35 ng/mL
STANDARD_DEVIATION 1.39 • n=21 Participants
|
|
Estrone
|
17.6 pg/mL
STANDARD_DEVIATION 18.3 • n=5 Participants
|
12.4 pg/mL
STANDARD_DEVIATION 17.4 • n=7 Participants
|
3.1 pg/mL
STANDARD_DEVIATION 0.0 • n=5 Participants
|
5.11 pg/mL
STANDARD_DEVIATION 6.7 • n=4 Participants
|
10.0 pg/mL
STANDARD_DEVIATION 14.7 • n=21 Participants
|
|
Sirtuin-1 gene expression by real time polimerase chain reaction "RT-PCR"
|
10.4 arbitrary unit
STANDARD_DEVIATION 1.28 • n=5 Participants
|
11.6 arbitrary unit
STANDARD_DEVIATION 1.38 • n=7 Participants
|
11.4 arbitrary unit
STANDARD_DEVIATION 1.26 • n=5 Participants
|
10.6 arbitrary unit
STANDARD_DEVIATION 1.15 • n=4 Participants
|
11.0 arbitrary unit
STANDARD_DEVIATION 1.33 • n=21 Participants
|
|
RAGE (receptor for advanced glycation end-products) gene expression "RT-PCR"
|
11.3 arbitrary unit
STANDARD_DEVIATION 1.24 • n=5 Participants
|
12.7 arbitrary unit
STANDARD_DEVIATION 1.65 • n=7 Participants
|
10.9 arbitrary unit
STANDARD_DEVIATION 1.68 • n=5 Participants
|
10.5 arbitrary unit
STANDARD_DEVIATION 1.76 • n=4 Participants
|
11.3 arbitrary unit
STANDARD_DEVIATION 1.74 • n=21 Participants
|
|
Platelet aggregation by adenosine diphosphate (ADP)
|
86.13 %
STANDARD_DEVIATION 4.06 • n=5 Participants
|
88.90 %
STANDARD_DEVIATION 5.87 • n=7 Participants
|
84.20 %
STANDARD_DEVIATION 7.80 • n=5 Participants
|
88.45 %
STANDARD_DEVIATION 3.65 • n=4 Participants
|
86.92 %
STANDARD_DEVIATION 5.74 • n=21 Participants
|
|
Platelet aggregation by epinephrine
|
84.23 %
STANDARD_DEVIATION 3.90 • n=5 Participants
|
83.42 %
STANDARD_DEVIATION 10.22 • n=7 Participants
|
66.88 %
STANDARD_DEVIATION 25.92 • n=5 Participants
|
81.20 %
STANDARD_DEVIATION 18.27 • n=4 Participants
|
78.93 %
STANDARD_DEVIATION 17.72 • n=21 Participants
|
|
Nonesterified fatty acid
|
25.73 mmol/L
STANDARD_DEVIATION 16.55 • n=5 Participants
|
18.64 mmol/L
STANDARD_DEVIATION 14.12 • n=7 Participants
|
29.75 mmol/L
STANDARD_DEVIATION 49.34 • n=5 Participants
|
24.17 mmol/L
STANDARD_DEVIATION 20.92 • n=4 Participants
|
24.67 mmol/L
STANDARD_DEVIATION 28.69 • n=21 Participants
|
|
Clot onset time
|
38.25 seconds
STANDARD_DEVIATION 4.16 • n=5 Participants
|
30.75 seconds
STANDARD_DEVIATION 9.58 • n=7 Participants
|
38.25 seconds
STANDARD_DEVIATION 4.00 • n=5 Participants
|
91.64 seconds
STANDARD_DEVIATION 177.95 • n=4 Participants
|
48.83 seconds
STANDARD_DEVIATION 86.58 • n=21 Participants
|
|
Clot complete
|
103.83 seconds
STANDARD_DEVIATION 13.67 • n=5 Participants
|
80.83 seconds
STANDARD_DEVIATION 12.01 • n=7 Participants
|
100.17 seconds
STANDARD_DEVIATION 14.32 • n=5 Participants
|
152.64 seconds
STANDARD_DEVIATION 211.01 • n=4 Participants
|
108.45 seconds
STANDARD_DEVIATION 102.45 • n=21 Participants
|
|
Slope
|
100.83 Pascal/min
STANDARD_DEVIATION 38.42 • n=5 Participants
|
165.42 Pascal/min
STANDARD_DEVIATION 60.43 • n=7 Participants
|
108.17 Pascal/min
STANDARD_DEVIATION 43.98 • n=5 Participants
|
158.36 Pascal/min
STANDARD_DEVIATION 37.85 • n=4 Participants
|
132.66 Pascal/min
STANDARD_DEVIATION 53.47 • n=21 Participants
|
|
Max Elasticity
|
1598.50 Pascal
STANDARD_DEVIATION 398.18 • n=5 Participants
|
2202.98 Pascal
STANDARD_DEVIATION 391.50 • n=7 Participants
|
1639.82 Pascal
STANDARD_DEVIATION 383.97 • n=5 Participants
|
2164.64 Pascal
STANDARD_DEVIATION 275.91 • n=4 Participants
|
1895.88 Pascal
STANDARD_DEVIATION 456.53 • n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days post-treatmentThe 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)".
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Direct Evaluation of the Sirtuin 1 Gene Expression
|
11.04 arbitrary unit relative to control gene
Standard Deviation 1.75
|
11.43 arbitrary unit relative to control gene
Standard Deviation 1.42
|
12.84 arbitrary unit relative to control gene
Standard Deviation 1.36
|
12.05 arbitrary unit relative to control gene
Standard Deviation 1.13
|
PRIMARY outcome
Timeframe: 30 days post-treatmentSirtuin plasma levels before and 30 days post-treatment
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Sirtuin
|
4.84 ng/mL
Standard Deviation 2.78
|
6.67 ng/mL
Standard Deviation 2.99
|
6.14 ng/mL
Standard Deviation 1.98
|
5.46 ng/mL
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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.
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
HDL-cholesterol "mg/dL"
|
43.00 "mg/dL"
Standard Deviation 10.37
|
53.33 "mg/dL"
Standard Deviation 15.11
|
41.08 "mg/dL"
Standard Deviation 9.10
|
62.92 "mg/dL"
Standard Deviation 15.16
|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
LDL-cholesterol "mg/dL"
|
125.50 "mg/dL"
Standard Deviation 29.93
|
153.58 "mg/dL"
Standard Deviation 45.92
|
126.33 "mg/dL"
Standard Deviation 33.47
|
134.25 "mg/dL"
Standard Deviation 34.27
|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
Lipoprotein(a)"mg/dL"
|
15.03 "mg/dL"
Standard Deviation 19.98
|
24.43 "mg/dL"
Standard Deviation 33.57
|
32.73 "mg/dL"
Standard Deviation 41.34
|
20.86 "mg/dL"
Standard Deviation 12.82
|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
total cholesterol "mg/dL"
|
196.08 "mg/dL"
Standard Deviation 31.67
|
239.08 "mg/dL"
Standard Deviation 47.12
|
193.83 "mg/dL"
Standard Deviation 37.20
|
211.50 "mg/dL"
Standard Deviation 41.79
|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
Triglycerides "mg/dL"
|
137.75 "mg/dL"
Standard Deviation 62.22
|
159.50 "mg/dL"
Standard Deviation 118.13
|
131.00 "mg/dL"
Standard Deviation 77.91
|
72.25 "mg/dL"
Standard Deviation 30.58
|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
C-reactive protein "mg/dL"
|
0.13 "mg/dL"
Standard Deviation 0.14
|
0.28 "mg/dL"
Standard Deviation 0.23
|
0.17 "mg/dL"
Standard Deviation 0.14
|
0.16 "mg/dL"
Standard Deviation 0.11
|
|
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
glucose "mg/dL"
|
99.83 "mg/dL"
Standard Deviation 16.29
|
97.33 "mg/dL"
Standard Deviation 12.51
|
89.92 "mg/dL"
Standard Deviation 5.78
|
91.17 "mg/dL"
Standard Deviation 6.19
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
Apolipoprotein A1 "g/dL"
|
1.33 "g/dL"
Standard Deviation 0.20
|
1.55 "g/dL"
Standard Deviation 0.24
|
1.29 "g/dL"
Standard Deviation 0.21
|
1.57 "g/dL"
Standard Deviation 0.29
|
|
Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
Apolipoprotein B "g/dL"
|
0.95 "g/dL"
Standard Deviation 0.19
|
1.13 "g/dL"
Standard Deviation 0.31
|
0.97 "g/dL"
Standard Deviation 0.27
|
0.93 "g/dL"
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Estradiol
|
38.92 "pg/mL"
Standard Deviation 13.60
|
34.81 "pg/mL"
Standard Deviation 12.73
|
42.13 "pg/mL"
Standard Deviation 14.26
|
29.05 "pg/mL"
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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.
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Platelet Aggregation.
Platelet aggregation by ADP "%"
|
88.03 percentage platelet aggregation
Standard Deviation 4.92
|
88.96 percentage platelet aggregation
Standard Deviation 4.15
|
87.32 percentage platelet aggregation
Standard Deviation 4.12
|
87.24 percentage platelet aggregation
Standard Deviation 12.06
|
|
Influence of the Sirtuin 1 System on Platelet Aggregation.
Platelet aggregation by norepinephrine "%"
|
81.06 percentage platelet aggregation
Standard Deviation 10.46
|
81.77 percentage platelet aggregation
Standard Deviation 16.91
|
74.43 percentage platelet aggregation
Standard Deviation 23.83
|
72.09 percentage platelet aggregation
Standard Deviation 27.37
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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.
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Biomarkers
Non sterified fatty acid "microUI/mL"
|
22.45 "microUI/mL"
Standard Deviation 10.32
|
23.73 "microUI/mL"
Standard Deviation 12.51
|
8.83 "microUI/mL"
Standard Deviation 8.73
|
24.67 "microUI/mL"
Standard Deviation 19.43
|
|
Influence of the Sirtuin 1 System on Biomarkers
Insulin "microUI/mL"
|
79.00 "microUI/mL"
Standard Deviation 54.55
|
80.58 "microUI/mL"
Standard Deviation 64.15
|
53.25 "microUI/mL"
Standard Deviation 32.28
|
67.08 "microUI/mL"
Standard Deviation 30.20
|
|
Influence of the Sirtuin 1 System on Biomarkers
Luteinizing hormone "microUI/mL"
|
3.93 "microUI/mL"
Standard Deviation 1.66
|
19.97 "microUI/mL"
Standard Deviation 7.01
|
4.50 "microUI/mL"
Standard Deviation 1.65
|
28.56 "microUI/mL"
Standard Deviation 11.77
|
|
Influence of the Sirtuin 1 System on Biomarkers
Follicle stimulating hormone "microUI/mL"
|
4.40 "microUI/mL"
Standard Deviation 2.26
|
57.78 "microUI/mL"
Standard Deviation 15.35
|
6.31 "microUI/mL"
Standard Deviation 3.71
|
79.79 "microUI/mL"
Standard Deviation 26.04
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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.
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
Norepinephrine "pg/dL"
|
219.33 "pg/dL"
Standard Deviation 99.24
|
227.83 "pg/dL"
Standard Deviation 92.13
|
190.83 "pg/dL"
Standard Deviation 124.82
|
329.00 "pg/dL"
Standard Deviation 194.11
|
|
Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
Estrone"pg/dL"
|
14.92 "pg/dL"
Standard Deviation 18.54
|
13.23 "pg/dL"
Standard Deviation 15.49
|
7.62 "pg/dL"
Standard Deviation 15.68
|
4.12 "pg/dL"
Standard Deviation 3.52
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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)"
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression
|
11.88 arbitrary unit relative to control gene
Standard Deviation 1.80
|
12.78 arbitrary unit relative to control gene
Standard Deviation 1.38
|
12.17 arbitrary unit relative to control gene
Standard Deviation 1.99
|
11.75 arbitrary unit relative to control gene
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
Clot onset time "sec"
|
38.00 "sec"
Standard Deviation 5.62
|
35.50 "sec"
Standard Deviation 5.50
|
40.42 "sec"
Standard Deviation 7.93
|
35.67 "sec"
Standard Deviation 5.82
|
|
Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
Clot complet "sec"
|
100.83 "sec"
Standard Deviation 17.47
|
89.00 "sec"
Standard Deviation 16.59
|
101.00 "sec"
Standard Deviation 23.68
|
86.83 "sec"
Standard Deviation 15.75
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Thromboelastography.
|
106.83 "Pascal/min"
Standard Deviation 50.13
|
158.67 "Pascal/min"
Standard Deviation 47.13
|
115.42 "Pascal/min"
Standard Deviation 67.38
|
156.75 "Pascal/min"
Standard Deviation 43.42
|
SECONDARY outcome
Timeframe: 30 days post-treatmentFor 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
Outcome measures
| Measure |
Men With Resveratrol
n=12 Participants
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
|
Women With Resveratrol
n=12 Participants
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
|
Men With Caloric Restriction
n=12 Participants
12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
Women With Caloric Restriction
n=12 Participants
12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days
|
|---|---|---|---|---|
|
Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.
|
1690.58 "Pascal"
Standard Deviation 522.54
|
2059.83 "Pascal"
Standard Deviation 337.48
|
1691.50 "Pascal"
Standard Deviation 380.49
|
2041.12 "Pascal"
Standard Deviation 318.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysWe will also compare women vs men baseline and final data.
Outcome measures
Outcome data not reported
Adverse Events
Men With Resveratrol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women With Resveratrol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Men With Caloric Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women With Caloric Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Antonio de Padua Mansur - Associate Professor
Heart Institute (InCor), University of São Paulo Medical School
Phone: 55-11-26615387
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place