Introduction
Methods and materials
Subjects
Entry | Baseline 0 week (T1) | 4 week (T2) | 8 week (T3) | 12 week (T4) |
---|---|---|---|---|
Phone interview Familiarization session General medical exam by a registered nurse to determine qualifications to participate in study. | Blood Collection * Clinical Chemistry * Thyroid Panel * Fasting Insulin Total Body Water DEXA Body Comp HR/Blood Pressure Dietary History Questionnaires | Total Body Water DEXA Body Comp HR/Blood Pressure Questionnaires | Total Body Water DEXA Body Comp HR/Blood Pressure Questionnaires | General Medical Exam Blood Collection * Clinical Chemistry *Thyroid Panel * Fasting Insulin Total Body Water DEXA Body Comp HR/Blood Pressure Dietary History Questionnaires |
Pre-Supplementation/Baseline Testing
Supplementation Protocol
Post-Supplementation Assessments
Procedures
Medical Monitoring
Dietary Inventories
Appetite Scale
Psychometric Inventory
Total Body Weight
Total Body Water
Body Composition & Bone Density
Heart Rate & Blood Pressure
Blood Samples
Data analysis
Results
Nutritional Intake
Variable | Group | Week 0 (T1) | Week 8 (T3) | Week 12 (T4) | Significance | |
---|---|---|---|---|---|---|
Fat (g/kg/d) | CF | 281.5 ± 87.5 | 243.2 ± 69.0 | 187.0 ± 55.8 | Group | 0.153 |
P | 337.0 ± 124.2 | 310.1 ± 99.1 | 219.0 ± 86.3 | Time | 0.002 | |
Group × Time | 0.696 | |||||
Carbohydrates (g/kg/d) | CF | 959.1 ± 278.7 | 903.5 ± 227.9 | 777.5 ± 303.2 | Group | 0.719 |
P | 959.7 ± 253.6 | 953.3 ± 269.2 | 831.5 ± 184.1 | Time | 0.025 | |
Group × Time | 0.676 | |||||
Protein (g/kg/d) | CF | 293.8 ± 112.0 | 270.8 ± 93.0 | 242.8 ± 80.7 | Group | 0.525 |
P | 318.5 ± 143.5 | 290.7 ± 129.9 | 282.1 ± 77.6 | Time | 0.213 | |
Group × Time | 0.831 | |||||
Energy Intake | CF | 7458 ± 1920 | 6833 ± 1259 | 5690 ± 1927 | Group | 0.299 |
(kcal/kg/d) | P | 8087 ± 2310 | 7772 ± 2165 | 6435 ± 1475 | Time | 0.007 |
Group × Time | 0.919 |
Medical Safety Analysis
Variable | Group | Week 0 (T1) | Week 12 (T4) | Significance | |
---|---|---|---|---|---|
White Blood Cells (thous/cum) | CF | 6.5 ± 1.8 | 7.9 ± 2.3 | Group | 0.030 |
P | 5.9 ± 1.7 | 5.1 ± 1.7 | Time | 0.366 | |
Group × Time | 0.007 | ||||
Absolute Lymphocytes (cells/mcl) | CF | 2161.2 ± 433.6 | 2771.0 ± 643.2 | Group | 0.051 |
P | 2084.4 ± 511.4 | 1945.8 ± 447.5 | Time | 0.043 | |
Group × Time | 0.003 | ||||
Calcium (mg/dl) | CF | 9.1 ± 0.1 | 9.3 ± 0.4 | Group | 0.894 |
P | 9.3 ± 0.2 | 9.1 ± 0.2 | Time | 0.904 | |
Group × Time | 0.030 | ||||
ALT (SGPT) (U/L) | CF | 11.8 ± 4.6 | 11.4 ± 3.4 | Group | 0.020 |
P | 22.5 ± 10.1 | 22.0 ± 13.8 | Time | 0.036 | |
Group × Time | 0.000 | ||||
Uric Acid (mg/dl) | CF | 4.2 ± 0.9 | 3.8 ± 1.0 | Group | 0.006 |
P | 3.9 ± 1.1 | 4.4 ± 1.4 | Time | 0.724 | |
Group × Time | 0.003 | ||||
Absolute Neutrophils (cells/mcl) | CF | 3791.9 ± 1273.0 | 4467.7 ± 1737.2 | Group | 0.042 |
P | 3270.7 ± 1251.3 | 2732.5 ± 596.0 | Time | 0.787 | |
Group × Time | 0.027 |
Body Composition
Variable | Group | Week 0 (T1) | Week 4 (T2) | Week 8 (T3) | Week 12 (T4) | Significance | |
---|---|---|---|---|---|---|---|
Body Weight (kg) | CF | 87.2 ± 12.4 | 86.8 ± 12.1 | 86.5 ± 12.8 | 86.6 ± 13.0 | Group | 0.987 |
P | 86.1 ± 12.5 | 86.1 ± 15.3 | 87.1 ± 14.3 | 87.4 ± 13.4 | Time | 0.492 | |
Group × Time | 0.121 | ||||||
Bone Mineral Area (cm2) | CF | 1772 ± 94 | 1772 ± 121 | 1755 ± 127 | 1781 ± 130 | Group | 0.148 |
P | 1846 ± 116 | 1861 ± 110 | 1855 ± 106 | 1844 ± 120 | Time | 0.929 | |
Group × Time | 0.756 | ||||||
Bone Mineral Content (g) | CF | 1781 ± 202 | 1788 ± 206 | 1759 ± 226 | 1803 ± 223 | Group | 0.412 |
P | 1872 ± 237 | 1874 ± 223 | 1874 ± 232 | 1870 ± 242 | Time | 0.663 | |
Group × Time | 0.601 | ||||||
Bone Mineral Density (g/cm2) | CF | 1.0 ± 0.08 | 1.0 ± 0.07 | 0.9 ± 0.07 | 1.0 ± 0.07 | Group | 0.923 |
P | 1.0 ± 0.08 | 1.0 ± 0.07 | 1.0 ± 0.08 | 1.0 ± 0.08 | Time | 0.367 | |
Group × Time | 0.578 | ||||||
Fat Mass (kg) | CF | 33.82 ± 8.00 | 33.77 ± 8.38 | 33.66 ± 8.17 | 33.61 ± 8.37 | Group | 0.638 |
P | 31.27 ± 7.22 | 31.69 ± 7.94 | 32.20 ± 8.70 | 32.36 ± 8.22 | Time | 0.336 | |
Group × Time | 0.161 | ||||||
Lean Mass (kg) | CF | 44.65 ± 5.75 | 44.40 ± 4.88 | 44.69 ± 5.44 | 44.59 ± 5.53 | Group | 0.446 |
P | 46.40 ± 6.18 | 46.47 ± 6.45 | 47.01 ± 5.97 | 47.05 ± 5.62 | Time | 0.168 | |
Group × Time | 0.212 | ||||||
Lean + BMC (kg) | CF | 46.43 ± 5.88 | 46.18 ± 5.01 | 46.45 ± 5.57 | 46.40 ± 5.66 | Group | 0.440 |
P | 48.27 ± 6.36 | 48.35 ± 6.63 | 48.88 ± 6.16 | 48.92 ± 5.81 | Time | 0.154 | |
Group × Time | 0.211 | ||||||
Total Mass (kg) | CF | 80.25 ± 12.42 | 79.96 ± 11.93 | 80.11 ± 12.59 | 80.017 ± 12.7 | Group | 0.948 |
P | 79.54 ± 12.70 | 80.04 ± 13.60 | 81.08 ± 13.81 | 81.28 ± 13.01 | Time | 0.139 | |
Group × Time | 0.080 | ||||||
Body Fat (%) | CF | 41.8 ± 4.7 | 41.8 ± 5.0 | 41.6 ± 4.4 | 41.6 ± 4.8 | Group | 0.243 |
P | 39.0 ± 3.7 | 39.5 ± 4.0 | 39.2 ± 4.6 | 39.3 ± 4.3 | Time | 0.923 | |
Group × Time | 0.395 | ||||||
Body Water (%) | CF | 43.9 ± 4.0 | 44.1 ± 3.6 | 45.5 ± 3.8 | 45.3 ± 4.3 | Group | 0.289 |
P | 46.1 ± 3.2 | 46.1 ± 3.6 | 46.1 ± 3.2 | 47.3 ± 5.2 | Time | 0.200 | |
Group × Time | 0.802 |
Psychological Profiles
Appetite Profiles
Variable | Group | Week 0 (T1) | Week 4 (T2) | Week 8 (T3) | Week 12 (T4) | Significance | |
---|---|---|---|---|---|---|---|
Appetite | CF | 4.8 ± 0.3 | 4.7 ± 1.4 | 4.4 ± 1.1 | 4.5 ± 0.7 | Group | 0.829 |
P | 5.1 ± 0.8 | 4.1 ± 1.6 | 4.3 ± 1.4 | 5.1 ± 1.1 | Time | 0.673 | |
Group × Time | 0.581 | ||||||
Hunger | CF | 4.0 ± 1.2 | 3.8 ± 1.0 | 4.0 ± 1.8 | 3.1 ± 1.5 | Group | 0.054 |
P | 4.9 ± 1.1 | 4.0 ± 1.5 | 4.1 ± 1.1 | 5.2 ± 1.0 | Time | 0.645 | |
Group × Time | 0.165 | ||||||
Satisfaction from Food | CF | 5.8 ± 1.7 | 5.0 ± 0.5 | 4.4 ± 1.2 | 4.7 ± 1.9 | Group | 0.138 |
P | 6.1 ± 1.4 | 5.9 ± 1.3 | 5.5 ± 1.9 | 5.8 ± 1.1 | Time | 0.026 | |
Group × Time | 0.242 | ||||||
Feeling of Fullness | CF | 5.8 ± 1.3 | 4.7 ± 0.9 | 5.0 ± 2.1 | 4.1 ± 1.3 | Group | 0.040 |
P | 6.3 ± 1.3 | 5.9 ± 1.7 | 6.1 ± 1.8 | 6.4 ± 1.5 | Time | 0.086 | |
Group × Time | 0.042 | ||||||
Amount of Energy | CF | 5.9 ± 2.0 | 5.2 ± 1.3 | 5.5 ± 2.5 | 5.5 ± 1.9 | Group | 0.611 |
P | 5.8 ± 1.2 | 6.0 ± 1.2 | 5.9 ± 1.4 | 5.8 ± 1.7 | Time | 0.781 | |
Group × Time | 0.785 | ||||||
Overall Quality of Food | CF | 4.8 ± 1.5 | 5.1 ± 1.8 | 4.5 ± 1.1 | 4.0 ± 1.7 | Group | 0.102 |
P | 5.2 ± 1.4 | 5.7 ± 1.0 | 5.6 ± 1.3 | 5.6 ± 1.4 | Time | 0.472 | |
Group × Time | 0.134 |