Table 4.
Estimated Marginal Means for Cognitive Tests after 6 months of treatment with Soy Isoflavones or Placebo.
| Domain | Test | Placebo Treated MEAN VALUE (SE) |
Isoflavone Treated MEAN VALUE (SE) |
P-value | |
|---|---|---|---|---|---|
| Cognitive Outcomes | Global Cognition | Mini-Mental State Examination (MMSE) (N=59) | 21.3 (1.0) | 23.4 (1.0) | 0.15 |
| Verbal Memory | List Learning Delayed Free Recall; Number of words recalled (N=57) | 1.8 (0.50) | 2.2 (0.50) | 0.56 | |
| Logical Memory Delayed Recall; Number of story elements recalled (n=57) | 4.6 (0.95) | 5.7 (0.9) | 0.40 | ||
| Executive Function | Mazes; Time to complete (N=53) | 32.2 (5.3) | 22.6 (5.4) | 0.22 | |
| Trail Making Test B; Time to complete (N=52) | 95.5 (16.7) | 95.7 (16.0) | 0.99 | ||
| Stroop Color Word Test; Time to complete (N=54) | 105.0 (12.0) | 91.8 (12.0) | 0.44 | ||
| Language Executive Function |
Category Fluency; Number of words generated (N=55) | 21.5 (1.9) | 25.7 (2.0) | 0.13 | |
| Phonemic Fluency; Number of words generated (N=56) | 25.9 (2.4) | 35.2 (2.4) | 0.04* | ||
| Visual Memory | Complex Figure Delayed Recall; Number of points (N=57) | 10.6 (1.8) | 13.4 (1.8) | 0.27 | |
| Benton Visual Retention Test; Number of correct figures (N=56) | 2.7 (0.4) | 2.8 (0.4) | 0.78 | ||
| Benton Visual Retention; Number of errors (N=56) | 14.5 (1.2) | 13.1 (1.2) | 0.42 | ||
| Visual Motor | Complex Figure Copy; Number of points (N=57) | 27.6 (1.1) | 29.0 (1.1) | 0.35 | |
| Grooved Pegboard Dominant Hand; Time to complete (N= (N=51) | 134.3 (17.6) | 149.8 (16.6) | 0.53 | ||
| Grooved Pegboard Non-Dominant Hand; Time to complete (N=48) | 161.8 (24.4) | 156.0 (22.4) | 0.87 | ||
| Mood Outcomes | Depression | Geriatric Depression Scale – Subject Report (N=57) | 2.1 (0.6) | 3.3 (0.6) | 0.41 |
| Geriatric Depression Scale – Study Partner Report (N=57) | 5.2 (0.7) | 6.3 (0.7) | 0.25 | ||
| Multiple- Mood States |
Profile of Mood States (POMS) – Tension Scale (N=56) | 8.2 (1.3) | 9.3 (1.3) | 0.55 | |
| POMS – Depression Scale (N=56) | 9.0 (1.8) | 11.4 (1.7) | 0.34 | ||
| POMS – Anger Scale (N=56) | 6.8 (1.4) | 8.3 (1.4) | 0.45 | ||
| POMS – Fatigue Scale (N=56) | 10.3 (1.2) | 10.3 (1.2) | 0.97 | ||
| POMS – Vigor Scale (N=56) | 12.4 (1.1) | 12.0 (1.1) | 0.79 | ||
| POMS – Confusion Scale (N=56) | 15.5 (1.1) | 14.0 (1.1) | 0.35 |
All means were adjusted for covariates including age at baseline (76.4 years) and education (14.5 years). Subjects performed similarly on tests at baseline with the exception of Phonemic Fluency. Individuals randomized to receive Soy Isoflavones out-performed those on Placebo in Baseline Phonemic Fluency.
*
When model is corrected for baseline differences, difference between groups is no longer significant.