Clinical Study

Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial

Table 1

Enrollment clinical and anthropometric characteristics of healthy volunteers.

ParameterFrequency
()(n; %)
GenderMale(; 42.9%)
Female(; 57.1%)
Body composition phenotypeNWL(; 42.9%)
MHO(; 57.1%)
Mean ± SDMedian (min–max)
()()
Age (years)32.00 ± 12.2227.00 (23.00–64.00)
SBP (mmHg)119.31 ± 7.79120.00 (100.00–130.00)
DBP (mmHg)74.46 ± 6.6576.00 (60.00–80.00)
TC (mg/dL)156.54 ± 14.36160.00 (138.00–184.00)
HDL-C (mg/dL)61.92 ± 4.5763.00 (54.00–69.00)
LDL-C (mg/dL)88.69 ± 13.2386.00 (63.00–110.00)
Tg (mg/dL)67.77 ± 32.4658.00 (32.00–134.00)
Glycemia (mg/dL)72.46 ± 5.6272.00 (62.00–79.00)
Insulin (μU/mL)7.58 ± 4.096.81 (3.32–17.68)
Height (cm)165.68 ± 9.29163.80 (151.50–183.60)
Weight (kg)66.61 ± 10.0669.00 (51.10–80.90)
BMI (kg/m2)23.62 ± 2.4723.46 (20.20–28.00)
Waist circumference (cm)76.15 ± 6.9776.80 (66.00–90.40)
Hip circumference (cm)99.12 ± 8.0497.90 (89.00–116.00)
Waist/hip ratio0.77 ± 0.060.77 (0.69–0.91)
Biceps skinfold (mm)7.21 ± 4.376.90 (2.20–15.13)
Triceps skinfold (mm)16.68 ± 6.6116.80 (7.40–26.50)
Subscapular skinfold (mm)13.55 ± 4.6713.80 (6.50–21.90)
Suprailiac skinfold (mm)12.26 ± 6.149.87 (5.40–25.60)
FM% (skinfolds)24.92 ± 8.0827.29 (12.74–39.05)
TBW (L)36.13 ± 6.7634.00 (27.90–46.40)
ECW (L)16.81 ± 2.7615.80 (12.50–21.60)
ICW (L)19.31 ± 4.4018.20 (13.20–26.40)
Phase angle5.81 ± 0.785.80 (4.40–7.00)
TBFat% (DXA)28.26 ± 10.4330.00 (11.10–44.90)
TBFat (kg)18.60 ± 7.8416.64 (7.84–36.13)
TBLean (kg)45.14 ± 10.8042.45 (30.99–62.62)
Energy intake (kcal)1717.48 ± 546.091750.32 (1107.20–2585.01)
Carbohydrates (g)245.89 ± 80.09234.82 (152.79–413.19)
Protein (g)76.30 ± 19.9576.79 (47.37–119.97)
Lipids (g)54.11 ± 26.4142.94 (18.78–95.88)

All results were expressed as mean ± standard deviation (SD) (number of replicates = 3) and median (minimum and maximum). SBP: systolic blood pressure; DBP: diastolic blood pressure; TC: total cholesterol; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; Tg: triglycerides; BMI: body mass index; FM: fat mass; TBW: total body water; ECW: extracellular water; ICW: intracellular water; TBFat: total body fat; TBLean: total body lean.