Evidence suggests that fasting, during which only water is consumed, results in potentially health promoting physiological effects. However, peer-reviewed research assessing the safety of water-only fasting is lacking. To address this, we conducted a chart review to describe adverse events (AEs) that occurred during medically supervised, water-only fasting. Electronic charts from patient visits to a residential medical facility from 2006 to 2011 were reviewed. Patients who were at least 21 years of age and water-only fasted for ≥2 consecutive days with a refeeding period equal to half of the fast length were included. Out of 2539 charts, 768 visits met our inclusion and exclusion criteria. AEs were abstracted from chart notes and classified according to CTCAE (v4.03) and MedDRA (v12.1) terminology. Descriptive analysis of AEs is reported. During the protocol period, the highest grade AE (HGAE) in 555 visits was a grade 2 event or lower, in 212 visits it was a grade 3 event, in 1 visit it was a grade 4 event, and there were no grade 5 events. There were 2 (0.002%) visits with a serious adverse event (SAE). The majority of AEs identified were mild (n = 4490, 75%) in nature and known reactions to fasting. To our knowledge, this is the most comprehensive analysis of AEs experienced during medically supervised, water-only fasting conducted to date. Overall, our data indicate that the majority of AEs experienced were mild to moderate and known reactions to fasting. This suggests that the protocol used in this study can be safely implemented in a medical setting with minimal risk of a SAE.

Epidemiologic evidence, reinforced by clinical and laboratory studies, shows that the rich Western diet is the major underlying cause of death and disability (e.g, from cardiovascular disease and type 2 diabetes) in Western industrialized societies. The objective of this study is to document the effects that eating a low-fat (≤10% of calories), high-carbohydrate (~80% of calories), moderate-sodium, purely plant-based diet ad libitum for 7 days can have on the biomarkers of cardiovascular disease and type 2 diabetes. Retrospective analysis of measurements of weight, blood pressure, blood sugar, and blood lipids and estimation of cardiovascular disease risk at baseline and day 7 from 1615 participants in a 10-day residential dietary intervention program from 2002 to 2011. Wilcoxon’s signed-rank test was used for testing the significance of changes from baseline. The median (interquartile range, IQR) weight loss was 1.4 (1.8) kg (p < .001). The median (IQR) decrease in total cholesterol was 22 (29) mg/dL (p < .001). Even though most antihypertensive and antihyperglycemic medications were reduced or discontinued at baseline, systolic blood pressure decreased by a median (IQR) of 8 (18) mm Hg (p < .001), diastolic blood pressure by a median (IQR) of 4 (10) mm Hg (p < .001), and blood glucose by a median (IQR) of 3 (11) mg/dL (p < .001). For patients whose risk of a cardiovascular event within 10 years was >7.5% at baseline, the risk dropped to 5.5% (>27%) at day 7 (p < .001). A low-fat, starch-based, vegan diet eaten ad libitum for 7 days results in significant favorable changes in commonly tested biomarkers that are used to predict future risks for cardiovascular disease and metabolic diseases.

Purpose: Glutathione depletion has been documented in several disease states, and exogenous administration has been hypothesized to have therapeutic potential for some conditions. In an effort to reach target tissues of the sinuses and central nervous system (CNS), glutathione is being prescribed as an intranasal spray, although no literature exists to support this mode of administration. The objective of this study was to describe patient-reported outcomes in a population of individuals who have been prescribed intranasal reduced glutathione, (in)GSH. Methods: A survey was designed to assess individuals' perception of tolerability, adverse events, and health benefits associated with (in)GSH use. Using a pharmacy database, 300 individuals were randomly selected to receive a survey; any individual who had received one or more prescriptions for (in)GSH between March 2009 and March 2011 was eligible for participation. Results: Seventy (70) individuals returned the survey (23.3% response rate) from 20 different states. Reported indications for (in)GSH prescriptions were multiple chemical sensitivity (MCS) (n=29), allergies/sinusitis (n=25), Parkinson disease (PD) (n=7), Lyme disease (n=3), fatigue (n=2), and other (n=10). Of the respondents, 78.8% (n=52) reported an overall positive experience with (in)GSH, 12.1% (n=8) reported having experienced adverse effects, and 62.1% (n=41) reported having experienced health benefits attributable to (in)GSH use. Over 86% of respondents considered the nasal spray to be comfortable and easy to administer. Conclusions: This is the first study to evaluate patient-reported outcomes among individuals across the country who have been prescribed (in)GSH. The majority of survey respondents considered (in)GSH to be effective and without significant adverse effects. (in)GSH should be further evaluated as a method of treating respiratory and CNS diseases where free-radical burden is a suspected contributor to disease progression.

Thesis (Master's)--University of Washington, 2012

Context: As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol (25(OH)D), health care providers are measuring it frequently. Providers and patients are faced with treatment choices when low status is identified. Objective: To compare the safety and efficacy of three vitamin D₃ dietary supplements with different delivery matrices. Setting and Design: A 12-week, parallel group, single-masked, clinical trial was conducted in Seattle, Washington and Kailua Kona, Hawaii. Sixty-six healthy adults with (25(OH)D) <33 ng/mL were randomly assigned to take one of three D₃ supplements, ie, a chewable tablet (TAB), an oil-emulsified drop (DROP), or an encapsulated powder (CAP) at a label-claimed dose of 10,000 IU/day. Actual D₃ content was assessed by a third party and the results adjusted based on the actual D₃ content administered. Mean change in 25(OH)D/mcg D₃ administered; difference in the proportion of D₃ insufficient participants (ie, 25(OH)D ≤30 ng/mL) reaching sufficiency (ie, 25(OH)D ≥30 ng/mL); and mean change in serum 1, 25-dihydroxycholecalciferol were measured. Results: In two of the three products tested, the measured vitamin D₃ content varied considerably from the label-claimed dose. Differences in 25(OH)D/mcg D₃ administered were significantly different between groups (P = .04; n = 55). Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB (P < .05) but not than CAP. TAB was not different from CAP. The proportions reaching sufficiency were: 100% (TAB and CAP) and 80% (DROP) (P = .03 between groups; n = 55). 1, 25-Dihydroxycholecalciferol did not change significantly in any group. Conclusions: Oil-emulsified vitamin D₃ supplements resulted in a greater mean change in serum 25(OH)D concentration, but fewer patients reaching vitamin D sufficiency, than chewable or encapsulated supplements.