Table 2.
Anthropometric, patient-reported, and clinical outcome measures using an intention-to-treat analysis pre-KD and post-KD intervention
| Baseline (pre-diet) (n=64) | 3 months (on-diet) (n=59) | 6 months (on-diet) (n=57) | |||
|---|---|---|---|---|---|
|
|
|
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| Mean±SD | Δ Change from baseline | P value | Δ Change from baseline | P -value | |
| Anthropometric measures | |||||
|
| |||||
| Body Mass Index (BMI) | 33.2±7.0 | −2.9±1.5 | <0.001 | −3.4±2.2 | <0.001 |
|
| |||||
| Waist Circumference (cm) | 104.8±14.2 | −6.7±5.2 | <0.001 | −9.8±7.4 | <0.001 |
|
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| Bod Pod Assessment | |||||
|
| |||||
| Fat Mass (kg) | 41.3±16.1 | — | — | −7.7±5.4 | <0.001 |
|
| |||||
| Fat-Free Mass (kg) | 51.9±10.7 | — | — | −1.4±1.9 | <0.001 |
|
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| Resting Metabolic Rate (kcal/day) | 1510.8±306.2 | — | — | −67.8±60.1 | <0.001 |
|
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| Patient reported outcomes | |||||
|
| |||||
| Beck’s Depression Inventory | 8.5±5.3 | −3.3±3.8 | <0.001 | −3.8±4.5 | <0.001 |
|
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| Modified Fatigue Impact Scale | 33.3±18.1 | −11.6±12.7 | <0.001 | −14.4±14.9 | <0.001 |
|
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| MS Fatigue Severity Scale* | 21.9±8.8 | −2.7±5.4 | 0.015 | −3.4±5.8 | 0.002 |
|
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| MS Quality of Life-54* | |||||
|
| |||||
| Physical QoL | 66.9±16.3 | +9.2 ± 10.3 | <0.001 | +12.0 ± 14.0 | <0.001 |
|
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| Mental QoL | 71.3±16.6 | +8.5 ± 13.6 | 0.002 | +11.2 ± 18.3 | <0.001 |
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| Clinical outcome measures | |||||
|
| |||||
| EDSS | 2.3±0.9 | −0.4±0.6 | <0.001 | −0.5±0.6 | <0.001 |
|
| |||||
| MS Functional Composite | |||||
|
| |||||
| Timed 25-foot walk (sec) | 5.0±1.5 | — | — | −0.1±0.7 | 0.33 |
|
| |||||
| 9-Hole Peg Test (sec) | 21.5±3.6 | — | — | −1.1±1.5 | <0.001 |
|
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| PASAT (# correct) | 46.6±9.0 | — | — | +0.2 ± 4.9 | 0.815 |
|
| |||||
| SDMT (# correct) | 61.1±10.1 | — | — | +1.1 ± 5.6 | 0.18 |
|
| |||||
| 6 min walk (feet) | 1631±302 | — | — | +78 ± 137 | <0.001 |
|
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| Low Contrast Visual Acuity | |||||
|
| |||||
| 100 OU (# correct) | 56±9 | — | — | +0.6 ± 5 | 0.355 |
|
| |||||
| 2.5 OU (# correct) | 36±11 | — | — | +0.2 ± 6 | 0.856 |
|
| |||||
| 1.25 OU (# correct) | 27±12 | — | — | +1.2 ± 10 | 0.390 |
Results represent mean±SD as change from baseline to reported time point (eg, 3 months or 6 months on KD).
Bolded denotes a significant p-value.
*
These surveys were only completed on the last 45 subjects, such that at baseline n=44, 3 months n=40 and 6 months n=39.
†
EDSS, Expanded Disability Status Scale; KD, ketogenic diet; MS, multiple sclerosis; SDMT, Symbol Digit Modality Test.