Table 2. Body Weight, Glycemic Control, and Cardiometabolic Risk Factorsa.
| Variable | No. of participants | Participant group, mean change from baseline (95% CI) | Mean difference between groups (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|
| Baseline | 6 mo | TRE | CR | Control | TRE vs CR | TRE vs control | CR vs control | |
| Weight | ||||||||
| Body weight, % lost | 75 | 68 | −4.28 (−6.26 to −2.31) | −2.50 (−3.83 to −1.18) | −0.72 (−2.14 to 0.69) | −1.78 (−4.09 to 0.53) | −3.56 (−5.92 to −1.20)b | −1.78 (−3.67 to 0.11) |
| Body weight, kg | 75 | 68 | −4.52 (−6.73 to −2.30) | −2.63 (−3.99 to −1.27) | −1.07 (−2.70 to 0.57) | −1.89 (−4.42 to 0.64) | −3.45 (−6.13 to −0.77)b | −1.56 (−3.63 to 0.51) |
| Glycemic control | ||||||||
| HbA1c level, % | 72 | 66 | −0.72 (−1.25 to −0.18) | −0.75 (−1.20 to −0.30) | 0.19 (−0.30 to 0.68) | 0.04 (−0.64 to 0.72) | −0.91 (−1.61 to −0.20)c | -0.94 (−1.59 to −0.30)c |
| Time in euglycemic range, % | 67 | 56 | 4.78 (−3.52 to 13.08) | 10.65 (2.65 to 18.65) | −7.81 (−24.90 to 9.27) | −5.87 (−17.03 to 5.28) | 12.59 (−5.70 to 30.89) | 18.46 (0.31 to 36.62) |
| Mean glucose level, mg/dL | 67 | 56 | −11.02 (−24.85 to 2.82) | −17.03 (−30.49 to −3.58) | 31.51 (−4.54 to 67.56) | 6.02 (−12.67 to 24.70) | −42.53 (−79.73 to −5.33)c | −48.55 (−85.55 to −11.54)c |
| Medication effect score | ||||||||
| OHA | 75 | 69 | −0.12 (−0.26 to 0.01) | 0.04 (−0.15 to 0.23) | 0.03 (−0.15 to 0.21) | −0.16 (−0.38 to 0.06) | −0.15 (−0.37 to 0.07) | 0.01 (−0.25 to 0.26) |
| Insulin | 75 | 69 | −0.02 (−0.10 to 0.07) | −0.02 (−0.05 to 0.01) | 0.00 (0.00 to 0.00) | 0.01 (−0.08 to 0.09) | −0.02 (−0.10 to 0.07) | −0.02 (−0.05 to 0.01) |
| Body composition | ||||||||
| Fat mass, kg | 71 | 65 | −2.77 (−4.36 to −1.18) | −1.92 (−3.20 to −0.65) | −0.28 (−1.46 to 0.90) | −0.85 (−2.82 to 1.13) | −2.49 (−4.41 to −0.58)c | −1.65 (−3.33 to 0.04) |
| Lean mass, kg | 71 | 65 | −0.97 (−2.04 to 0.10) | −0.46 (−1.15 to 0.23) | −0.59 (−1.49 to 0.32) | −0.51 (−1.74 to 0.72) | −0.38 (−1.74 to 0.98) | 0.13 (−0.98 to 1.23) |
| Visceral fat mass, kg | 70 | 64 | −0.16 (−0.36 to 0.05) | −0.18 (−0.32 to −0.04) | −0.07 (−0.18 to 0.04) | 0.02 (−0.21 to 0.26) | −0.09 (−0.31 to 0.13) | −0.11 (−0.28 to 0.06) |
| Waist circumference, cm | 74 | 67 | −3.92 (−5.93 to −1.91) | −3.97 (−6.03 to −1.92) | −0.48 (−1.66 to 0.71) | 0.05 (−2.74 to 2.84) | −3.44 (−5.71 to −1.18)c | −3.50 (−5.80 to −1.20)c |
| BMI | 75 | 68 | −1.78 (−2.63 to −0.94) | −0.89 (−1.36 to −0.41) | −0.37 (−0.95 to 0.22) | −0.90 (−1.83 to 0.04) | −1.41 (−2.41 to −0.42)c | −0.52 (−1.25 to 0.21) |
| Blood pressure, mm Hg | ||||||||
| SBP | 75 | 65 | −4.45 (−9.98 to 1.07) | −3.91 (−9.33 to 1.52) | 1.52 (−4.45 to 7.49) | −0.55 (−8.05 to 6.96) | −5.98 (−13.87 to 1.92) | −5.43 (−13.25 to 2.39) |
| DBP | 75 | 65 | −2.88 (−6.92 to 1.16) | −1.47 (−3.86 to 0.93) | 0.06 (−3.22 to 3.34) | −1.41 (−5.97 to 3.14) | −2.94 (−7.98 to 2.10) | −1.52 (−5.46 to 2.41) |
| Heart rate, bpm | 75 | 65 | −2.48 (−6.79 to 1.84) | −1.77 (−6.03 to 2.49) | −0.84 (−6.44, to 4.75) | −0.71 (−6.61 to 5.19) | −1.63 (−8.51 to 5.24) | −0.93 (−7.77 to 5.91) |
| Plasma lipid levels, mg/dL | ||||||||
| Total cholesterol | 71 | 60 | −0.18 (−10.55 to 10.20) | −8.12 (−22.86 to 6.63) | −1.88 (−15.67 to 11.90) | 7.94 (−9.47 to 25.35) | 1.71 (−14.97 to 18.38) | −6.23 (−25.76 to 13.30) |
| LDL cholesterol | 71 | 60 | −0.23 (−9.56 to 9.10) | −4.57 (−16.19 to 7.04) | −4.86 (−16.76 to 7.05) | 4.34 (−10.04 to 18.73) | 4.63 (−9.99 to 19.24) | 0.28 (−15.81 to 16.38) |
| HDL cholesterol | 71 | 60 | 3.20 (0.88 to 5.52) | −0.23 (−3.68 to 3.23) | 1.02 (−1.57 to 3.62) | 3.43 (−0.60 to 7.47) | 2.18 (−1.19 to 5.54) | −1.25 (−5.44 to 2.93) |
| Triglycerides | 71 | 60 | −15.43 (−37.92 to 7.06) | −9.53 (−25.14 to 6.08) | 3.70 (−13.32 to 20.73) | −5.90 (−32.3 to 20.59) | −19.13 (−46.42 to 8.16) | −13.23 (−35.62 to 9.15) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CR, calorie restriction; DBP, diastolic blood pressure; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; OHA, oral hypoglycemic agent; SBP, systolic blood pressure; TRE, time-restricted eating.
SI conversion factors: To convert cholesterol to mmol/L, multiply by 0.0258; glucose to mmol/L, multiply by 0.0555; HbA1c to proportion of total hemoglobin, multiply by 0.01; triglycerides to mmol/L, multiply by 0.0113.
a
Means were estimated using an intention-to-treat analysis using a linear mixed model with 95% CIs for each parameter from baseline by diet group.
b
Indicates statistical significance using Bonferroni-adjusted 2-tailed P < .017.
c
Indicates statistical significance using P < .05.