Table 3.
Secondary and Exploratory Outcomes: Cardiometabolic Outcomes
| TRE |
SOC |
Between Groups | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Outcomes | Baseline | 3-Month | Delta (95% CI) | Percent Change | Baseline | 3-Month | Delta (95% CI) | Percent Change | Delta TRE-SOC |
Percent Change | |
|
| |||||||||||
| Body Composition | |||||||||||
| Weight, kg | 89.94 (16.98) | 86.96 (17.06) | −2.98 (−4.11 to −1.84) |
−3.3% | 89.25 (16.48) | 87.93 (16.23) | −1.32 (−2.07 to −0.57) |
−1.5% | −1.66 (−3.00 to −0.32) |
−1.8% | |
| BMI, kg/m2 | 31.50 (4.06) | 30.38 (4.37) | −1.11 (−1.51 to −0.72) |
−3.5% | 30.95 (4.03) | 30.55 (4.11) | −0.39 (−0.66 to −0.13) |
−1.3% | −0.77 (−1.37 to −0.17) |
−2.2% | |
| Percent Body Fat, % | 37.70 (6.90) | 36.34 (7.35) | −1.36 (−2.00 to −0.73) |
−3.6% | 38.62 (6.62) | 38.51 (6.81) | −0.11 (−0.71 to 0.49) |
−0.4% | −1.25 (−2.12 to −0.38) |
−3.2% | |
| Trunk Fat^, % | 39.43 (5.88) | 37.88 (6.50) | −1.55 (−7.87 to −0.90) |
−3.9% | 40.33 (5.99) | 40.18 (6.20) | −0.15 (−0.83 to 0.53) |
−0.4% | −1.40 (−2.37 to −0.43) |
−3.5% | |
| Total Fat Mass, g | 33263.73 (8306.52) | 31023.51 (8490.32) | −2240.22 (−3044.43 to 1376.01) |
−6.7% | 33572.58 (7634.67) | 33163.47 (8027.05) |
−409.11 (−1093.11 to 273.89) |
−1.3% | −1801.11 (−2871.06 to −731.16) |
−5.4% | |
| Total Lean Mass, g | 52504.06 (11954.31) | 52228.52 (12246.54) | −275.53 (−773.69 to 222.62) |
−0.5% | 51544.89 (12182.13) |
50977.86 (11991.96) |
−567.03 (−1107.95 to −26.11) |
−1.1% | 291.50 (−434.31 to 1017.30) |
+0.6% | |
| Total BMC, g | 2458.77 (543.28) | 2462.99 (551.40) | 4.22 (−11.54 to 19.98) |
0.0% | 2439.74 (548.23) |
2442.64 (567.37) | 2.89 (−13.55 to 19.34) |
0.0% | 1.32 (−21.18 to 23.82) |
0.0% | |
| Cardiometabolic Parameters | |||||||||||
| LDL Direct Cholesterol^ | |||||||||||
| mmol/L | 3.12 (1.07) | 2.84 (1.03) | −0.27 (−0.41 to −0.13) |
−8.7% | 3.02 (0.92) | 2.98 (1.07) | −0.04 (−0.16 to 0.09) |
−1.2% | −0.24 (−0.42 to −0.05) |
−7.5% | |
| mg/dL | 120.48 (41.47) | 110.00 (39.95) | −10.48 (−15.83 to −5.13) |
116.78 (35.62) | 115.41 (41.44) | −1.37 (−6.38 to 3.64) |
−9.11 (−16.36 to −1.87) |
||||
| LDL particle number, nmol/L | 1527.87 (485.45) | 1402.40 (490.54) | −125.46 (−191.90 to −59.03) |
−8.2% | 1533.25 (423.01) | 1485.25 (445.25) | −48.00 (−104.64 to 8.64) |
−3.1% | −77.46 (−163.72 to 8.80) |
−5.1% | |
| HDL Cholesterol^ | |||||||||||
| mmol/L | 1.36 (0.40) | 1.33 (0.35) | −0.04 (−0.07 to 0.00) |
−2.6% | 1.39 (0.41) | 1.39 (0.38) | −0.01 (−0.05 to 0.03) |
−0.7% | −0.03 (−0.08 to 0.03) |
−1.9% | |
| mg/dL | 52.70 (15.43) | 51.33 (13.62) | −1.37 (−2.90 to 0.15) |
53.94 (16.01) | 53.57 (14.85) | −0.37 (−1.98 to 1.24) |
−1.00 (−3.19 to 1.19) |
||||
| Triglycerides^ | |||||||||||
| mmol/L | 1.66 (0.72) | 1.57 (0.76) | −0.09 (−0.22 to 0.05) |
−5.3% | 1.73 (0.87) | 1.57 (0.65) | −0.16 (−0.30 to 0.02) |
−9.1% | 0.07 (−10.7 to 23.02) |
+3.8% | |
| mg/dL | 146.81 (63.49) | 139.04 (67.19) | −7.78 (−19.78 to 4.23) |
152.87 (76.78) | 138.93 (57.34) | −13.94 (−26.17 to −1.82) |
6.17 (−10.70 to 23.03) |
||||
| hs-CRP^, mg/L | 2.44 (2.65) | 2.25 (2.53) | −0.19 (−0.66 to 0.28) |
−7.8% | 2.63 (2.78) | 2.54 (3.13) | −0.09 (−0.89 to 0.71) |
−3.4% | −1.09 (−3.25 to 1.07) |
−4.4% | |
| SBP, mm/Hg | 131.76 (15.22) | 128.28 (12.27) | −3.48 (−7.87 to 0.91) |
−2.6% | 127.89 (13.96) | 126.17 (13.84) | −1.72 (−5.91 to 2.47) |
−1.3% | −1.76 (−7.76 to 4.24) |
−1.3% | |
| DBP, mm/Hg | 75.65 (10.93) | 71.67 (10.23) | −3.98 (−7.06 to −0.90) |
−5.3% | 74.88 (11.79) | 73.44 (10.97) | −1.44 (−3.81 to 0.93) |
−1.9% | −2.54 (−6.39 to 1.30) |
−3.4% | |
Data displayed as Mean (SD) and Mean (95% Confidence Interval) for delta values. Paired t-tests were used to assess within-group changes and Mixed ANOVAs were used to assess changes between TRE and SOC (time x group) with age as a covariate. Body Composition was assessed via DXA body scan. N=54 per group for all outcomes except for the following: DXA measurements: SOC n=52; LDL particle number, n=52 per group (missing data due to lab error: interference); hs-CRP: TRE n=53. There was no pattern of missingness between groups (Supplemental Table 2). TRE = time-restricted eating, SOC = standard of care, BMI = body mass index, BMC = bone mineral content, LDL = low-density lipoprotein, HDL = high-density lipoprotein, hs-CRP = high sensitivity C-reactive protein, SBP = systolic blood pressure, DBP = diastolic blood pressure.