Background
Methods
Study design and intervention
Study participants
Randomization and blinding
Compliance and adverse event monitoring
Bioavailablity: Serum vitamin E concentration
Data collection and outcome measures
Statistical analysis
Results
Participants
Variables | Placebo | Low TT | High TT | P value |
---|---|---|---|---|
Number | 28 | 29 | 30 | |
Age [y] | 59.4±6.3 | 58.5±6.7 | 61.2±7.2 | 0.431 |
Weight [kg] | 74.3±17.9 | 76.3±14.8 | 74.3±16.8 | 0.680 |
Height [cm] | 160.0±6.2 | 163.7±6.5 | 155.6±27.1 | 0.107 |
Body mass index [kg/m2] | 28.9±6.5 | 28.5±5.0 | 28.8±5.8 | 0.986 |
Bone mineral density [T-score] | ||||
Femoral Neck | −1.66±0.65 | −1.52±0.82 | −1.34±1.17 | 0.795 |
Trochanter | −1.06±0.95 | −1.04±0.79 | −0.85±1.30 | 0.945 |
Total spine | 0.79±0.89 | −0.87±0.85 | −0.53±1.10 | 0.654 |
L1-L4 | −0.67±0.99 | −0.72±1.17 | 0.59±1.23 | 0.919 |
Serum 25 (OH)D [ng/mL] | 35.79±9.13 | 35.45±9.70 | 34.27±9.97 | 0.634 |
Serum TSH [mIU/L] | 2.25±1.01 | 2.45±1.46 | 2.52±1.71 | 0.944 |
Serum HbA1c [%] | 5.66±0.35 | 5.81±0.34 | 5.56±0.36 | 0.011 |
Medical history [n (%)] | ||||
Broken bone as adult | 6 (21.43) | 7 (24.14) | 8 (26.67) | 0.897 |
Osteoarthritis | 3 (12.00) | 5 (20.83) | 3 (11.54) | 0.584 |
Diabetes | 2 (7.14) | 2 (6.90) | 0 (0.00) | 0.331 |
Asthma | 4 (14.29) | 3 (10.34) | 2 (6.67) | 0.636 |
Use of HRT in the past 2 yr | 10 (35.71) | 8 (27.59) | 6 (20.00) | 0.409 |
Steroid or glucocorticoid use | 5 (17.86) | 4 (13.79) | 3 (10.00) | 0.687 |
Prescribed osteoporosis drugs | 1 (3.57) | 4 (13.79) | 7 (23.33) | 0.093 |
Serum tocotrienol and tocopherol concentrations
VE | Week 0 | Week 6 | Week 12 | Overall P Value | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Placeboa | Low TT | High TT | Placebo | Low TT | High TT | Placebo | Low TT | High TT | ||
α-tocopherol | 14.64 (6.89) | 14.3 (5.71) | 12.38 (6.35) | 14.03 (7.4) | 13.56 (4.43) | 13.67 (5.39) | 16.17 (6.44) | 15.01 (5.64) | 12.42 (6.31) | 0.771 |
β-tocopherol | 1.86 (1.86) | 3.21 (3.70) | 2.72 (2.26) | 3.07 (2.49) | 2.26 (2.19) | 2.50 (1.92) | 2.43 (2.35) | 2.82 (2.66) | 2.57 (2.04) | 0.571 |
δ-tocopherol | 1.17 (1.22) | 1.59 (2.52) | 0.94 (1.31) | 1.44 (2.41) | 1.64 (2.26) | 1.98 (1.43) | 1.43 (2.37) | 2.38 (3.23) | 1.84 (1.25) | 0.649 |
γ-tocopherol | 2.58 (2.71) | 3.79 (3.32) | 3.18 (2.15) | 3.13 (2.75) | 4.38 (3.13) | 3.27 (1.83) | 3.79 (3.61) | 4.23 (3.49) | 2.57 (2.07) | 0.189 |
α-tocotrienol | 0.92 (1.69) | 1.73 (3.45) | 1.82 (2.23) | 2.68 (3.73) | 1.89 (2.81) | 0.96 (1.25) | 0.87 (1.84) | 1.20 (1.93) | 1.79 (2.27) | 0.847 |
β-tocotrienol | 0.34 (0.70) | 0.11 (0.44) | 0.49 (0.97) | 0.61 (0.87) | 0.59 (0.91) | 0.33 (0.61) | 0.20 (0.54) | 0.12 (0.31) | 0.91 (1.40) | 0.341 |
δ-tocotrienol | 0.54 (0.92) | 1.06 (2.34) | 0.77 (1.08) | 1.05 (2.39) | 1.93 (1.81) | 2.32 (1.33) | 1.14 (1.84) | 3.19 (2.71) | 2.59 (2.10) | 0.042 |
γ-tocotrienol | 0.40 (0.84) | 0.77 (2.61) | 1.04 (2.56) | 1.58 (4.83) | 1.46 (2.99) | 1.27 (2.09) | 1.08 (2.65) | 2.71 (4.25) | 1.74 (3.24) | 0.307 |
Blood chemistry profiles
Variable | Week 0 | Week 6 | Week 12 | Overall P Value | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Placeboa | Low TT | High TT | Placebo | Low TT | High TT | Placebo | Low TT | High TT | ||
AST (U/L) | 23.01 (10.68) | 20.76 (6.57) | 20.77 (4.95) | 21.46 (5.53) | 20.76 (6.76) | 22.07 (7.97) | 21 (5.23) | 20.21 (9.39) | 21.9 (7.63) | 0.515 |
ALT (U/L) | 23.75 (11.49) | 19.9 (8.35) | 19.03 (7.83) | 20.82 (8.77) | 19.66 (8.88) | 20.5 (10.34) | 21.14 (8.67) | 18.72 (8.65) | 19.57 (10.76) | 0.494 |
Bilirubin (mg/dL) | 0.53 (0.19) | 0.52 (0.14) | 0.57 (0.15) | 0.46 (0.21) | 0.48 (0.13) | 0.43 (0.11) | 0.5 (0.19) | 0.47 (0.15) | 0.47 (0.12) | 0.583 |
ALP (U/L) | 72.75 (14.68) | 79.59 (15.53) | 79.23 (22.96) | 74.04 (16.95) | 76.28 (18.04) | 75.23 (16.56) | 74.64 (15.6) | 75.14 (16.31) | 74.4 (16.99) | 0.730 |
BUN (mg/dL) | 14.46 (3.48) | 16.41 (4.6) | 16.57 (4.26) | 14.86 (3.33) | 15.62 (3.53) | 17.07 (4.18) | 15.54 (3.96) | 16.97 (3.74) | 16.67 (4.44) | 0.120 |
Creatinine (mg/dL) | 0.79 (0.12) | 0.85 (0.13) | 0.83 (0.12) | 0.82 (0.12) | 0.87 (0.15) | 0.86 (0.15) | 0.82 (0.13) | 0.89 (0.17) | 0.83 (0.12) | 0.111 |
Ca (mg/dL) | 9.62 (0.38) | 9.54 (0.37) | 9.48 (0.29) | 9.44 (0.35) | 9.41 (0.36) | 9.37 (0.39) | 9.57 (0.34) | 9.55 (0.53) | 9.5 (0.28) | 0.607 |
Na (mmol/L) | 138.86 (3.43) | 139.72 (1.56) | 139.27 (2.33) | 139.5 (2.85) | 140.03 (2.5) | 140.1 (2.17) | 139.75 (1.9) | 140.48 (2.35) | 140.37 (2.51) | 0.346 |
K (mmol/L) | 3.99 (0.28) | 4.03 (0.36) | 4.02 (0.35) | 3.83 (0.24) | 3.77 (0.29) | 3.78 (0.4) | 3.84 (0.32) | 3.91 (0.31) | 3.79 (0.39) | 0.986 |
Cl (mmol/L) | 103.71 (3.55) | 104.1 (2.55) | 104.1 (2.92) | 103.61 (2.81) | 103.55 (2.32) | 104.5 (1.87) | 103.29 (2.68) | 103.9 (3.02) | 104.13 (3.04) | 0.314 |
CO2 (mmol/L) | 21.68 (2.28) | 22.48 (2.29) | 22.87 (2.61) | 19.79 (2.22) | 21.1 (1.97) | 20.83 (2.35) | 20.89 (1.83) | 21.45 (1.74) | 20.67 (2.92) | 0.086 |
Glucose (mg/dL) | 90.61 (10.78) | 88.21 (13.91) | 85.8 (15.05) | 87.43 (11.81) | 83.34 (12.29) | 83.27 (14.1) | 84.75 (11.78) | 83.83 (12.74) | 83.83 (11.75) | 0.282 |
Protein, total (g/dL) | 7.19 (0.41) | 7.23 (0.48) | 7.17 (0.54) | 7.2 (0.37) | 7.24 (0.4) | 7.2 (0.45) | 7.29 (0.33) | 7.24 (0.44) | 7.31 (0.41) | 0.810 |
Albumin (g/dL) | 4.39 (0.26) | 4.36 (0.21) | 4.35 (0.26) | 4.32 (0.24) | 4.28 (0.2) | 4.26 (0.18) | 4.41 (0.19) | 4.33 (0.21) | 4.38 (0.19) | 0.474 |
Globulin (g/dL) | 2.8 (0.35) | 2.87 (0.41) | 2.82 (0.45) | 2.89 (0.3) | 2.97 (0.41) | 2.95 (0.39) | 2.87 (0.28) | 2.91 (0.37) | 2.94 (0.38) | 0.468 |
Albumin/globulin | 1.59 (0.22) | 1.55 (0.25) | 1.59 (0.26) | 1.52 (0.19) | 1.48 (0.23) | 1.46 (0.21) | 1.55 (0.16) | 1.52 (0.2) | 1.52 (0.22) | 0.451 |
Quality of life
Domain | Week 0 | Week 12 | Overall P Value | ||||
---|---|---|---|---|---|---|---|
Placeboa | Low TT | High TT | Placebo | Low TT | High TT | ||
Physical function | 89.64 (12.24) | 83.1 (16.71) | 88 (13.68) | 77.22 (10.13) | 69.29 (16.82) | 74.66 (10.93) | 0.779 |
Role-physical | 92.19 (11.98) | 87.5 (18.3) | 89.79 (15.09) | 93.75 (11.63) | 84.15 (21) | 92.71 (12.07) | 0.293 |
Bodily pain | 71.43 (16.04) | 68.28 (19.65) | 71 (13.98) | 72.22 (15.77) | 71.07 (19.5) | 71 (16.26) | 0.761 |
General health | 80.18 (16.03) | 78.07 (14.7) | 83.5 (15.86) | 80.56 (17.42) | 78.57 (15.76) | 83.67 (14.78) | 0.754 |
Vitality | 66.29 (16.52) | 63.58 (19.7) | 66.46 (17.71) | 65.97 (16.84) | 67.63 (20.2) | 73.54 (15.8) | 0.079 |
Social function | 94.2 (15.02) | 92.24 (14.72) | 91.67 (16.52) | 93.06 (15.24) | 89.29 (23) | 94.58 (12.14) | 0.167 |
Role-emotional | 89.29 (19.62) | 92.24 (14.07) | 93.89 (10.48) | 90.74 (13.54) | 91.67 (16.67) | 93.61 (9.71) | 0.818 |
Mental health | 80.71 (12.82) | 84.31 (12.44) | 80.17 (15.51) | 82.04 (16.42) | 84.82 (14.37) | 83.33 (13.22) | 0.637 |
Body composition and physical activity
Variable | Week 0 | Week 12 | Overall P Value | ||||
---|---|---|---|---|---|---|---|
Placeboa | Low TT | High TT | Placebo | Low TT | High TT | ||
Body Composition | |||||||
BMI (kg/m2) | 28.95 (6.47) | 28.47 (4.98) | 28.77 (5.78) | 27.88 (6.44) | 28.37 (5.28) | 28.95 (6.01) | 0.345 |
Fat (%) | 39.13 (7.4) | 39.41 (6.89) | 39.01 (7.48) | 38.97 (7.22) | 39.81 (7.28) | 39.37 (7.59) | 0.959 |
Weight (kg) | 74.26 (17.94) | 76.34 (14.76) | 74.33 (16.76) | 72.87 (16.99) | 75.56 (15.25) | 74.36 (16.72) | 0.504 |
Physical activity profile | |||||||
Exercise frequency (sessions/week) | 2.14a (0.85) | 1.96ab (0.88) | 1.60b (0.62) | 2.19 (0.62) | 2.0 (0.86) | 1.75 (0.80) | 0.869 |
Exercise time (min/session) | 30.26 (22.53) | 31.07 (27.36) | 34.30(19.08) | 34.74(23.32) | 29.69(26.45) | 39.83(25.93) | 0.318 |
Nutrient intake
Variable | Week 0 | Week 12 | Overall P Value | ||||
---|---|---|---|---|---|---|---|
Placeboa | Low TT | High TT | Placebo | Low TT | High TT | ||
Total calories (kcal) | 1685.9 (624.72) | 2399.8 (1549.82) | 1928.2 (810.37) | 1610.4 (550.15) | 2128.6 (1382.71) | 2211.9 (1816.89) | 0.111 |
Carbohydrates (g) | 199.8 (86.99) | 266.5 (169.59) | 232.5 (106.84) | 190.2 (73.18) | 232.9 (159.45) | 264.0 (241.36) | 0.233 |
Total sugars (g) | 90.7 (52.64) | 123.6 (77.6) | 112.8 (60.48) | 87.2 (42.48) | 103.3 (68.72) | 124.1 (126.57) | 0.192 |
Total fiber (g) | 21.7 (8.99) | 27.8(19.94) | 24.1 (10.73) | 20.7 (8.67) | 26.7 (19.18) | 29.4 (26.49) | 0.252 |
Total fat (g) | 65.9 (26.97) | 104.4 (71.73) | 72.7 (33.8) | 63.3 (24.00) | 95.4 (61.70) | 84.5 (62.57) | 0.215 |
Cholesterol (mg) | 204.5 (99.95) | 323.7 (245.7) | 297.2 (190.79) | 212.5 (95.05) | 268.0 (196.27) | 309.8 (256.2) | 0.278 |
Saturated fat (g) | 20.6 (10.61) | 33.5 (25.52) | 25.1 (15.02) | 19.7 (8.13) | 28.0 (18.52) | 26.6 (21.59) | 0.213 |
Monounsaturated (g) | 25.0 (10.02) | 40.2(27.25) | 25.90 (11.60) | 24.1 (9.04) | 38.7 (25.83) | 31.8 (21.11) | 0.201 |
Polyunsaturated (g) | 14.2 (6.27) | 20.9 (14.32) | 14.6 (6.66) | 13.7 (7.14) | 20.2 (14.56) | 18.3 (15.28) | 0.298 |
Protein (g) | 72.4 (27.83) | 101.2 (71.44) | 90.0(41.12) | 70.5 (23.93) | 91.2(74.78) | 105.0(97.63) | 0.293 |
Calcium (mg) | 1164.1 (587.92) | 1277.4 (730.38) | 1318.2(792.1) | 1184.6 (517.16) | 1044.3 (574.77) | 1219.5 (1044.16) | 0.373 |
Potassium (mg) | 2908.1 (1107.18) | 3892.8 (2582.54) | 3343.0(1560.48) | 2847.1 (972.19) | 3463.7 (2495.8) | 3970.2 (3551.94) | 0.202 |
Phosphorus (mg) | 1211.7 (486.11) | 1638.9 (1057.27) | 1480.8(655.18) | 1217.3 (408.83) | 1430.9 (1027.86) | 1655.4 (1476.94) | 0.309 |
Sodium (mg) | 1849.3 (826.99) | 2656 (1860.41) | 2337.2(963.73) | 1847.2 (719.41) | 2355.3 (1609.08) | 2609.3 (2047.47) | 0.257 |
Magnesium (mg) | 382.1 (183.15) | 490.1 (331.28) | 413.0(223.5) | 363.5 (148.08) | 405.1 (273.53) | 446.2 (437.75) | 0.396 |
Iron (mg) | 12.2 (4.64) | 17.2 (11.74) | 16.0 (9.24) | 12.4 (7.81) | 15.5 (12.2) | 18.2 (14.12) | 0.435 |
α-Carotene (μg) | 703.2 (548.58) | 1143.1 (2215.95) | 619.2 (475.97) | 713.0 (585.51) | 1180.0 (2996.32) | 1402.5 (2523.89) | 0.133 |
β-Carotene (μg) | 5288.3 (3804.98) | 6993.7 (9886.87) | 5531.6 (3336.1) | 5379.9 (4162.6) | 7229.7 (11,253.44) | 7927.5 (10,896.58) | 0.439 |
Vitamin D (IU) | 437.0 (400.57) | 443.7 (296.05) | 516.0 (403.89) | 412.5 (339.19) | 286.4 (256.39) | 382.7 (371.33) | 0.333 |
Vitamin E (mg) | 16.9 (35.42) | 29.7 (70.48) | 17.2 (19.49) | 18.5 (34.65) | 61.2 (80.46) | 26.3 (46.57) | 0.365 |
Vitamin K1 (μg) | 174.1 (132.15) | 217.9 (173.9) | 228.8 (133.54) | 178.5 (130.91) | 214.1 (179.3) | 253.0 (231.18) | 0.805 |
Vitamin C (mg) | 266.4 (351.41) | 224.5 (266.92) | 163.4 (211.03) | 300.2 (410.03) | 159.3 (226.95) | 209.8 (242.44) | 0.058 |
Thiamine (mg) | 3.6 (9.69) | 6.5 (14.13) | 5.4 (13.11) | 5.5 (13.72) | 3.5 (10.24) | 5.3 (12.86) | 0.762 |
Riboflavin (mg) | 4.2 (9.75) | 7.2 (14.11) | 6.2 (13.35) | 6.1 (13.56) | 4.0 (10.37) | 6.2 (13.17) | 0.744 |
Pyridoxine (mg) | 8.1 (29.29) | 7.1 (14.19) | 13.0 (34.1) | 8.0 (16.3) | 17.9 (39.61) | 11.5 (38.01) | 0.255 |
Vitamin B12 (μg) | 46.9 (146.1) | 51.5 (137.43) | 46.9 (127.98) | 70.3 (168.15) | 66.1 (168.15) | 11.8 (14.73) | 0.138 |
Folic acid (μg) | 153.7 (130.66) | 277.0 (263.85) | 234.0 (301.46) | 215.1 (235.85) | 161.1 (203.88) | 205.6 (191.8) | 0.121 |
Niacin (mg) | 25.6 (11.66) | 49.7 (57.12) | 34.2 (22.63) | 47.2 (78.42) | 30.3 (25.59) | 37.0 (32.63) | 0.186 |