TABLE 4.
Time point | P 2 | ||||||
---|---|---|---|---|---|---|---|
Variable and group | D0 | D28 | D56 | D84 | Time | Group | Time × group |
ITT analysis | |||||||
Weight, kg | |||||||
LPF | 84.8 ± 1.1 (103) | 83.13 ± 1.2 (89) | 82.53 ± 1.3 (79) | 82.53 ± 1.4 (73) | <0.001 | 0.012 | 0.007 |
HPF | 87.1 ± 1.1 (103) | 85.63,4 ± 1.2 (98) | 84.93,4 ± 1.2 (89) | 84.93,4 ± 1.2 (80) | — | — | — |
Body fat, % | |||||||
LPF | 44.4 ± 0.8 (103) | — | — | 43.13 ± 1.0 (71) | — | 0.462 | — |
HPF | 42.8 ± 0.8 (103) | — | — | 41.83 ± 1.0 (79) | — | — | — |
PP analysis | |||||||
Weight, kg | |||||||
LPF | 85.8 ± 0.3 (68) | 84.75 ± 0.3 (68) | 84.35 ± 0.3 (68) | 84.05 ± 0.3 (68) | <0.001 | 0.023 | 0.004 |
HPF | 85.7 ± 0.3 (65) | 84.05 ± 0.3 (65) | 83.05,6 ± 0.3 (65) | 82.45,6 ± 0.3 (65) | — | — | — |
Body fat, % | |||||||
LPF | 43.2 ± 0.2 (68) | — | — | 42.15 ± 0.2 (68) | <0.001 | 0.531 | 0.572 |
HPF | 43.2 ± 0.2 (65) | — | — | 41.95 ± 0.2 (65) | — | — | — |
Values are estimated marginal means ± SEs, with sample size in parentheses. For all variables except for body weight and % body fat, only the results from the per-protocol analysis are described. D, day of trial; ITT, intent-to-treat; HPF, group provided a high-protein, high-fiber supplement shake; LPF, group provided a low-protein, lower-fiber supplement shake; PP, per-protocol.
For the ITT analysis, between-group differences were assessed using ANCOVA, with time as a within-participants fixed effect, group as a between-participants fixed effect, and their interaction. For the PP analysis, noncompliant participants were removed, and data modeled using generalized least-squares regression with the same main and interaction effects, but with both baseline value (taken at D0) and sex as covariates.
Different from day 0, P < 0.05 (Wilcoxon signed-rank test).
Different from LPF at that time, P < 0.05 (Wilcoxon signed-rank test).
Different from day 0, P < 0.05 (Tukey-adjusted within-participant comparison).
Different from LPF at that time, P < 0.05 (Tukey-adjusted between-group comparison).