Two-Month Consumption of Orange Juice Enriched with Vitamin D3 and Probiotics Decreases Body Weight, Insulin Resistance, Blood Lipids, and Arterial Blood Pressure in High-Cardiometabolic-Risk Patients on a Westernized Type Diet: Results from a Randomized Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Study Design
2.3. Encapsulation of the Microbial Cultures and Orange Juice Inoculation
2.4. Dietary Assessment, Physical Activity Assessment, and Subjective Appetite
2.5. Blood Sampling and Laboratory Methods
2.6. Blood Pressure (BP)
2.7. Pulse Wave Velocity (PWV) and Central Blood Pressure
2.8. Statistical Analysis
3. Results
3.1. Macro- and Selected Micronutrient Intakes at Baseline and at the End of 8 Weeks
3.2. Anthropometric Characteristics of the Participants at Baseline and at the End of the 8-Week Period
3.3. Biochemical Characteristics of the Participants at Baseline and after 8 Weeks
3.4. Peripheral and Central BP at Baseline and at the End of the 8-Week Study Period
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Enriched OJ with Vitamin D3 and Probiotics Group (n = 26) | Conventional OJ (Control) Group (n = 24) | p-Value | |
---|---|---|---|
Gender | |||
Male, n (%) | 10 (39%) | 7 (29%) | 0.35 |
Age, years (SD) | 49 ± 2 | 48 ± 2 | 0.71 |
Height, cm (SD) | 169 ± 2 | 166 ± 2 | 0.43 |
Drug treatment | |||
No drug treatment | 17 (65%) | 13 (54%) | 0.65 |
Antihypertensives, n (%) | 2 (8%) | 1 (4%) | |
Antihyperlipidemic, n (%) | 3 (12%) | 3 (13%) | |
Antihypertensive and antihyperlipidemic, n (%) | 0 (0%) | 1 (4%) | |
Alcohol consumption, n (%) | 17 (65%) | 14 (58%) | 0.32 |
Smoking, n (%) | 17 (65%) | 14 (58%) | 0.84 |
Physical activity level, n (%) | |||
Low | 18 (69%) | 8 (33%) | 0.02 |
Moderate | 6 (23%) | 8 (33%) | |
High | 2 (8%) | 8 (33%) |
Enriched with Vitamin D3 and Probiotics OJ Group (n = 26) | Control OJ Group (n = 24) | Interaction (Intervention × Time) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 8 Weeks | pa | Baseline | 8 Weeks | pa | pb | Coef. | 95% CI | p0–8 | |
Energy (kcal) | 1767 ± 94 | 1471 ± 86 | 0.002 | 1599 ± 101 | 1572 ± 117 | 0.83 | 0.23 | −269.8 | (−553.2, 13.7) | 0.06 |
Protein (g) | 75 ± 4 | 65 ± 5 | 0.02 | 73 ± 6 | 65 ± 5 | 0.18 | 0.82 | −1.4 | (−15.9, 13.1) | 0.85 |
Protein (kcal) | 300 ± 17 | 259 ± 19 | 0.02 | 294 ± 23 | 258 ± 21 | 0.18 | 0.82 | −5.7 | (−63.9, 52.5) | 0.85 |
Dietary fat (g) | 86 ± 6 | 66 ± 5 | 0.01 | 73 ± 4 | 79 ± 9 | 0.53 | 0.08 | −26.4 | (−48.9, −3.9) | 0.02 |
Dietary fat (kcal) | 771 ± 52 | 590 ± 42 | 0.01 | 657 ± 36 | 713 ± 80 | 0.53 | 0.08 | −237.6 | (−440.3, −34.9) | 0.02 |
Carbohydrates (g) | 162 ± 13 | 139 ± 11 | 0.04 | 143 ± 12 | 159 ± 15 | 0.25 | 0.28 | −38.7 | (−70.6, −6.8) | 0.02 |
Carbohydrates (kcal) | 684 ± 54 | 556 ± 44 | 0.04 | 572 ± 47 | 634 ± 61 | 0.25 | 0.28 | −154.8 | (−282.4, −27.3) | 0.02 |
Dietary fiber (g) | 14 ± 1 | 15 ± 3 | 0.84 | 13 ± 1 | 12 ± 1 | 0.53 | 0.45 | 1.7 | (−5.3, 8.8) | 0.63 |
Sugars (g) | 56 ± 5 | 56 ± 5 | 0.91 | 51 ± 6 | 67 ± 6 | 0.02 | 0.53 | −16.1 | (−31.1, −1.0) | 0.04 |
Saturated fat (g) | 23 ± 2 | 20 ± 2 | 0.16 | 21 ± 2 | 24 ± 3 | 0.39 | 0.52 | −5.4 | (−11.9, 1.1) | 0.11 |
Enriched with vitamin D3 and probiotics OJ group (n = 26) | Control OJ group (n = 24) | Interaction (intervention × time) | ||||||||
Baseline | 8 weeks | pa | Baseline | 8 weeks | pa | pb | Coef. | 95% CI | p0–8 | |
Trans fat (g) | 0 (0, 2) | 0 (0, 0) | 0.05 | 0 (0, 0) | 0 (0, 0) | 0.65 | 0.23 | 0.2 | (−0.1, 0.3) | 0.16 |
Monounsaturated fat (g) | 32 ± 3 | 25 ± 2 | 0.02 | 24 ± 2 | 24 ± 3 | 0.90 | 0.04 | −7.2 | (−15.3, 0.8) | 0.08 |
Polyunsaturated fat (g) | 12 (7, 19) | 8 (5, 10) | 0.002 | 9.7 (7, 15) | 7 (5, 11) | 0.08 | 0.53 | 39.3 | (−44.2, 122.9) | 0.36 |
Dietary cholesterol (g) | 125 ± 16 | 137 ± 18 | 0.54 | 153 ± 25 | 135 ± 29 | 0.57 | 0.35 | 30.5 | (−39.9, 101.0) | 0.40 |
Vitamin C (mg) | 88 ± 14 | 104 ± 8 | 0.25 | 51 ± 7 | 88 ± 9 | 0.002 | 0.02 | −21.6 | (−55.2, 11.99) | 0.21 |
Salt (g) | 4.9 ± 0.5 | 3.8 ± 0.3 | 0.02 | 4.0 ± 0.3 | 3.9 ± 0.4 | 0.71 | 0.15 | −0.9 | (−2.1, 0.3) | 0.15 |
Sodium (mg) | 1839 ± 185 | 1436 ± 125 | 0.03 | 1544 ± 121 | 1450 ± 153 | 0.59 | 0.19 | −308.3 | (−780.2, 163.6) | 0.20 |
Potassium (mg) | 1917 ± 98 | 1762 ± 91 | 0.15 | 1591 ± 136 | 1778 ± 89 | 0.19 | 0.06 | −342.8 | (−672.7, 12.8) | 0.04 |
Enriched with Vitamin D3 and Probiotics OJ Group (n = 26) | Control OJ Group (n = 24) | Interaction Intervention × Time (0–8 weeks) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 8 Weeks | pa | Baseline | 8 Weeks | pa | pb | Coef. | 95% CI | p0–8 | |
Body weight (kg) | 93 ± 4 | 91 ± 4 | <0.001 | 88 ± 5 | 87 ± 5 | 0.22 | 0.38 | −1.4 | (−2.4, −0.4) | 0.004 |
BMI (kg/m2) | 33 ± 1 | 32 ± 1 | 0.005 | 32 ± 1 | 31 ± 1 | 0.14 | 0.51 | −0.06 | (−1.1, −0.1) | 0.01 |
Body fat mass (kg) | 38 ± 2 | 36 ± 2 | 0.003 | 36 ± 2 | 35 ± 3 | 0.01 | 0.54 | −0.5 | (−1.6, 0.6) | 0.38 |
Body water (kg) | 41 ± 2 | 39 ± 2 | 0.28 | 38 ± 2 | 38 ± 2 | 0.84 | 0.46 | −1.9 | (−5.0, −1.2) | 0.23 |
Muscle mass (kg) | 28 (25) | 28 (24) | 0.45 | 26 (23) | 26 (24) | 0.32 | 0.43 | −0.3 | (−0.7, 0.2) | 0.27 |
Lean body mass (kg) | 55 ± 3 | 55 ± 3 | 0.26 | 52 ± 3 | 53 ± 3 | 0.27 | 0.46 | −0.5 | (−1.3, 0.3) | 0.18 |
Waist circumference (cm) | 108 ± 4 | 103 ± 3 | 0.10 | 101 ± 4 | 101 ± 4 | 0.95 | 0.18 | −4.7 | (−10.4, 1.1) | 0.11 |
Hip circumference (cm) | 116 ± 2 | 113 ± 2 | <0.001 | 112 ± 2 | 112 ± 2 | 0.76 | 0.13 | −4.2 | (−9.1, 0.6) | 0.08 |
Waist-to-hip circumference ratio (cm) | 0.9 ± 0.03 | 0.9 ± 0.02 | 0.67 | 0.9 ± 0.03 | 0.89 ± 0.02 | 0.64 | 0.56 | −0.005 | (−0.07, 0.07) | 0.91 |
BMR (kcal/day) | 1489 ± 109 | 1504 ± 95 | 0.85 | 1334 ± 87 | 1501 ± 92 | 0.04 | 0.28 | −156.6 | (−368.9, 55.7) | 0.15 |
Enriched with Vitamin D3 and Probiotics OJ Group (n = 26) | Control OJ Group (n = 24) | Interaction 0–8 Weeks | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 8 Weeks | pa | Baseline | 8 Weeks | pa | pb | Coef. | 95% CI | p0–8 | |
Fasting glucose (mg/dL) | 94 ± 2 | 91 ± 2 | 0.12 | 90 ± 2 | 87 ± 2 | 0.02 | 0.18 | −0.6 | (−5.1, 4.0) | 0.80 |
Fasting insulin (μU/mL) | 9 (7, 12) | 8 (6, 11) | 0.04 | 7 (4, 9) | 6 (4, 8) | 0.45 | 0.01 | −1.5 | (−3.9, 0.8) | 0.21 |
HOMA-IR | 2.2 (1.4, 2.9) | 2 (1.2, 2.5) | 0.02 | 1.4 (1.0, 2.2) | 1.2 (0.8, 1.7) | 0.28 | 0.02 | −0.4 | (−0.9, 0.2) | 0.23 |
FGI | 11 ± 0.9 | 13 ± 2 | 0.03 | 15 ± 1.5 | 16 ± 1.5 | 0.66 | 0.02 | −2.1 | (−1.0, 5.1) | 0.19 |
QUICKI | 0.3 ± 0.01 | 0.4 ± 0.01 | 0.006 | 0.4 ± 0.01 | 0.4 ± 0.01 | 0.23 | 0.01 | 0.007 | (−0.01, 0.02) | 0.27 |
Total cholesterol (mg/dL) | 199 ± 5 | 193 ± 5 | 0.05 | 184 ± 8 | 188 ± 7 | 0.45 | 0.13 | −10.3 | (−21.4, 0.9) | 0.07 |
LDL-C (mg/dL) | 113 ± 4 | 107 ± 4 | 0.004 | 104 ± 6 | 105 ± 5 | 0.77 | 0.22 | −6.9 | (−13.5, −0.5) | 0.03 |
HDL-C (mg/dL) | 50 ± 2 | 47 ± 2 | 0.01 | 51 ± 2 | 50 ± 2 | 0.85 | 0.84 | −2.5 | (−6.4, 1.3) | 0.20 |
Triglycerides (mg/dL) | 107 ± 10 | 105 ± 10 | 0.65 | 89 ± 11 | 90 ± 9 | 0.83 | 0.22 | −4.1 | (−21.2, 13.0) | 0.64 |
CRP (mg/dL) | 2 (1, 4) | 2 (1, 6) | 0.87 | 2 (1, 3) | 2 (1, 3) | 0.94 | 0.61 | −0.03 | (−0.8, 0.8) | 0.95 |
IL-6 (pg/mL) | 2 (2, 3) | 2 (2, 3) | 0.55 | 2 (2, 2) | 2 (2, 3) | 1.00 | 0.14 | 0.05 | (−0.5, 0.6) | 0.87 |
Vitamin D (ng/mL) | 20 ± 2 | 21 ± 1 | 0.29 | 22 ± 2 | 25 ± 2 | 0.007 | 0.45 | −1.9 | (−4.8, 1.0) | 0.19 |
Urea (mg/dL) | 28 ± 1 | 28 ± 2 | 0.79 | 31 ± 3 | 32 ± 2 | 0.52 | 0.23 | −0.7 | (−4.5, 3.2) | 0.74 |
Enriched with Vitamin D3 and Probiotics OJ Group (n = 26) | Control OJ Group (n = 24) | Interaction 0–8 Weeks | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 8 Weeks | pa | Baseline | 8 Weeks | pa | pb | Coef. | 95% CI | p0–8 | |
SBP (mmHg) | 127 ± 3 | 120 ± 2 | 0.002 | 124 ± 2 | 118 ± 2 | 0.01 | 0.48 | −0.0 | (−6.8, 5.1) | 0.77 |
DBP (mmHg) | 82 ± 3 | 77 ± 2 | 0.02 | 79 ± 2 | 77 ± 2 | 0.43 | 0.27 | −4.1 | (−9.5, 1.3) | 0.14 |
Central SBP (mmHg) | 117 ± 3 | 116 ± 4 | 0.74 | 120 ± 5 | 113 ± 3 | 0.25 | 0.57 | 5.5 | (−7.1, 18.1) | 0.39 |
Central DBP (mmHg) | 78 ± 2 | 77 ± 2 | 0.60 | 78 ± 2 | 76 ± 2 | 0.57 | 0.93 | 0.5 | (−4.3, 5.3) | 0.84 |
Augmentation index, Alx (%) | 4 (−19, 21) | 6 (−8.8, 12.3) | 0.75 | 12 (−35, 30) | 7 (−36, 13.5) | 0.22 | 0.20 | 16.2 | (−8.8, 41.2) | 0.21 |
PWV (m/s) | 8 (7, 9) | 8 (7, 9) | 0.82 | 8 (8, 10) | 8 (7.3, 8) | 0.03 | 0.12 | 16.2 | (−8.9, 41.2) | 0.26 |
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Papakonstantinou, E.; Zacharodimos, N.; Georgiopoulos, G.; Athanasaki, C.; Bothou, D.-L.; Tsitsou, S.; Lympaki, F.; Vitsou-Anastasiou, S.; Papadopoulou, O.S.; Delialis, D.; et al. Two-Month Consumption of Orange Juice Enriched with Vitamin D3 and Probiotics Decreases Body Weight, Insulin Resistance, Blood Lipids, and Arterial Blood Pressure in High-Cardiometabolic-Risk Patients on a Westernized Type Diet: Results from a Randomized Clinical Trial. Nutrients 2024, 16, 1331. https://doi.org/10.3390/nu16091331
Papakonstantinou E, Zacharodimos N, Georgiopoulos G, Athanasaki C, Bothou D-L, Tsitsou S, Lympaki F, Vitsou-Anastasiou S, Papadopoulou OS, Delialis D, et al. Two-Month Consumption of Orange Juice Enriched with Vitamin D3 and Probiotics Decreases Body Weight, Insulin Resistance, Blood Lipids, and Arterial Blood Pressure in High-Cardiometabolic-Risk Patients on a Westernized Type Diet: Results from a Randomized Clinical Trial. Nutrients. 2024; 16(9):1331. https://doi.org/10.3390/nu16091331
Chicago/Turabian StylePapakonstantinou, Emilia, Nikolaos Zacharodimos, Georgios Georgiopoulos, Christina Athanasaki, Dionysia-Lydia Bothou, Sofia Tsitsou, Foteini Lympaki, Stamatia Vitsou-Anastasiou, Olga S. Papadopoulou, Dimitrios Delialis, and et al. 2024. "Two-Month Consumption of Orange Juice Enriched with Vitamin D3 and Probiotics Decreases Body Weight, Insulin Resistance, Blood Lipids, and Arterial Blood Pressure in High-Cardiometabolic-Risk Patients on a Westernized Type Diet: Results from a Randomized Clinical Trial" Nutrients 16, no. 9: 1331. https://doi.org/10.3390/nu16091331
APA StylePapakonstantinou, E., Zacharodimos, N., Georgiopoulos, G., Athanasaki, C., Bothou, D. -L., Tsitsou, S., Lympaki, F., Vitsou-Anastasiou, S., Papadopoulou, O. S., Delialis, D., Alexopoulos, E. C., Petsiou, E., Keramida, K., Doulgeraki, A. I., Patsopoulou, I. -M., Nychas, G. -J. E., & Tassou, C. C. (2024). Two-Month Consumption of Orange Juice Enriched with Vitamin D3 and Probiotics Decreases Body Weight, Insulin Resistance, Blood Lipids, and Arterial Blood Pressure in High-Cardiometabolic-Risk Patients on a Westernized Type Diet: Results from a Randomized Clinical Trial. Nutrients, 16(9), 1331. https://doi.org/10.3390/nu16091331