Table 2.
Outcomes between baseline and 8 weeks in intervention and control groups
| Outcome | Intervention diet | Usual diet control | Between group differences in change at week 8 (adjusted for baseline value)d | ||||
|---|---|---|---|---|---|---|---|
| Baseline | Week 8 | Baseline | Week 8 | Diff | Effect size | p value | |
| Weight (lbs) | 177.5 | 165.7* | 159.9 | 158.8 | − 9.0 | − 0.21 | < 0.01 |
| BMI | 29.7 | 27.8* | 28.4 | 28.2 | − 1.7 | − 0.25 | < 0.01 |
| Cardiometabolic outcomes | |||||||
| Total Cholesterol (mg/dL)a | 193.6 | 159.4* | 174.6 | 181.4 | − 35.3 | − 0.93 | < 0.01 |
| LDL Cholesterol (mg/dL)a | 104.6 | 82.2* | 92.3 | 97.9 | − 23.5 | − 0.75 | < 0.01 |
| Triglycerides (mg/dL)a | 111.1 | 113.0 | 106.7 | 118.4 | − 8.8 | − 0.21 | 0.55 |
| HDL (mg/dL)a | 66.7 | 54.7* | 60.8 | 59.8 | − 9.3 | − 0.60 | < 0.01 |
| Systolic BP (mmHg)b | 113.2 | 110.3 | 111.0 | 113.3 | − 3.9 | − 0.33 | 0.28 |
| Diastolic BP (mmHg)b | 71.3 | 68.8 | 65.3 | 66.7 | − 1.9 | − 0.16 | 0.50 |
| Glucose (mg/dL) | 101.5 | 93.8 | 114.4 | 117.3 | − 11.9 | − 0.45 | 0.16 |
| Insulin (uIU/L) | 16.8 | 11.2* | 11.4 | 12.1 | − 3.8 | − 0.39 | 0.12 |
| HOMA-IR | 4.4 | 2.7* | 3.2 | 3.5 | − 1.3 | − 0.43 | 0.10 |
| Hormonal markers | |||||||
| Sex Hormone Binding Globulin (nmol/L) | 74.3 | 98.2* | 89.0 | 78.9* | 33.4 | 0.84 | < 0.01 |
| Total Testosterone (ng/dL) | 23.7 | 23.7 | 16.8 | 15.6 | 2.7 | 0.19 | 0.21 |
| Free Testosterone (ng/dL) | 0.49 | 0.32 | 0.25 | 0.28 | − 0.01 | − 0.03 | 0.90 |
| DHEA (ug/dL) | 110.9 | 106.8 | 56.5 | 53.7 | 2.8 | 0.06 | 0.72 |
| IGF-1 (ng/mL) | 173.8 | 156.4* | 150.5 | 144.7 | − 7.9 | − 0.16 | 0.38 |
| IGFBP-3 (ng/mL) | 4966 | 4874 | 4415 | 4418 | − 23.7 | − 0.02 | 0.92 |
| Blood counts | |||||||
| White Blood Cells (1000/uL) | 3.7 | 3.3 | 4.8 | 4.7 | − 0.7 | − 0.37 | 0.06 |
| Neutrophils (1000/uL) | 2.0 | 1.9 | 3.0 | 2.8 | − 0.4 | − 0.25 | 0.16 |
| Lymphocytes (1000/uL) | 1.1 | 1.0 | 1.3 | 1.3 | − 0.1 | − 0.17 | 0.38 |
| Hemoglobin (g/dL) | 12.3 | 12.2 | 12.1 | 12.4 | − 0.3 | − 0.27 | 0.37 |
| Platelet (1000/uL) | 215 | 206 | 222 | 223 | − 12.0 | − 0.18 | 0.34 |
| Cancer progression markers | |||||||
| CA 27.29 (U/mL)c | 25.7 | 24.6 | 84.9 | 97.5 | − 5.3 | − 0.08 | 0.23 |
| CA 15-3 (U/mL)c | 22.3 | 22.7 | 90.8 | 111.2 | − 5.2 | − 0.07 | 0.53 |
| CEA (ng/mL) | 3.1 | 3.2 | 7.9 | 10.2 | − 0.5 | − 0.07 | 0.54 |
Values are means
*p < 0.05 for within-group change
aOne intervention subject was excluded from the cholesterol analysis due to having stopped her cholesterol medication midway through the study
bOne intervention subject was excluded from the blood pressure analysis due to missing a baseline measurement
cOne intervention subject was excluded from the cancer marker analysis due to being an extreme outlier
dThe mean between-group difference in change from the baseline to 8 weeks was estimated by marginal means calculated via linear mixed effect model