TABLE 2.
Outcomec | H3-L6 Diet (N = 33)a | Control Diet (N = 37)a | Between Groups (Postb)s P-value | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Pre | Postb | Within Group P-valued | Pre | Postb | Within Group P-value | ||||||
Mean | SD | Mean | SD | Mean | SD | Mean | SD | ||||
Mood | 50.41 | 20.15 | 50.72 | 18.38 | 0.79 | 52.28 | 21.11 | 53.32 | 18.92 | 0.84 | 0.65 |
Energy | 44.97 | 22.30 | 44.44 | 19.38 | 0.96 | 42.88 | 23.26 | 43.97 | 20.36 | 0.99 | 0.43 |
Speed of thoughts | 46.13 | 22.70 | 42.86 | 21.76 | 0.30 | 44.28 | 23.38 | 44.43 | 24.79 | 0.84 | 0.87 |
Impulsivity (thoughts) | 28.02 | 27.08 | 24.76 | 25.57 | 0.39 | 25.20 | 24.08 | 22.06 | 25.65 | 0.85 | 0.93 |
Impulsivity (actions) | 20.97 | 22.82 | 18.47 | 21.21 | 0.08 | 19.62 | 20.69 | 17.44 | 22.24 | 0.83 | 0.79 |
Anxiety | 44.68 | 29.90 | 38.94 | 27.53 | 0.02* | 39.95 | 28.48 | 36.99 | 31.07 | 0.29 | 0.74 |
Irritability | 36.50 | 30.38 | 31.51 | 26.64 | 0.18 | 37.70 | 29.08 | 35.43 | 30.31 | 0.73 | 0.25 |
Pain | 29.44 | 28.93 | 31.08 | 29.56 | 0.06 | 32.33 | 27.95 | 37.83 | 28.72 | 0.25 | 0.40 |
Phone data for the Mood and Stress survey from 12 of the 82 randomized participants could not be used in this analysis. N = 2 participants did not log any usable phone date during the Baseline period (prior to week 0 randomization visit). N = 9 participants did not log any usable phone data during the follow-up period (after week 0 randomization visit), and N = 1 participant had no usable phone data for the study due to the malfunctioning date-time mechanism on the phone that they were provided. Therefore, N = 70 participants were included in the EMA analysis utilizing Mood and Stress surveys.
Note that ‘Pre’ data refers to all usable phone surveys logged between the participant’s date of enrollment and their date of randomization at week 0 visit (total of 1711 phone surveys included here).
Note that ‘Post’ data in this table references all aggregated phone survey data that was logged after week 0 randomization visit until each participant’s last attended Phase 1 study visit (total of 5512 phone surveys included here). This table utilizes a total of 7223 phone surveys from the N = 70 participants included in this analysis. Group comparisons between the diet groups were performed using two-sample t-tests or Wilcoxon rank-sum tests, as appropriate. Within each diet group, the pre-versus post-intervention comparisons were conducted using paired t-tests or Wilcoxon signed-rank tests, as appropriate.
Outcomes were measured twice per day on a visual analog scale (Range 0–100) using an Ecological Momentary Assessment paradigm. Exact question text provided in supplement.
P-values after multiple comparison adjustment based on the Bonferroni correction: Mood, 1.00; Energy,1.00; Speed of Thoughts, 1.00; Impulsivity (thoughts), 1.00; Impulsivity (actions), 0.16; Anxiety, 0.14; Irritability, 1.00; Pain, 0.48.
p < 0.05.