Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies
Original research article entitled Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome by Madeline Gibas for consideration for publication in a clinical journal. This research manuscript builds on previous landmark studies that report that major weight and fat mass loss in type II (T2D) patients who were fed a very low carbohydrate, ketogenic diet. In this manuscript, the investigators outline our research study that showed statistically significant (p < 0.05) changes over time in hemoglobin A1c, weight, BMI, body fat percentage and ketones for patients with metabolic syndrome who were fed a very low carbohydrate diet, ketogenic diet.
Purpose -Assessment of prolonged, physiological, dietary ketosis on pathological processes
induced by metabolic syndrome (MetS) including a reduction in fasting triglycerides, BMI and
body fat mass, a significant decrease and/or normalization of HgA1c and an increase in
resting metabolic rate.
Design - Qualitative
Setting - Bristlecone Health, Inc., Maple Grove, Minnesota
Subjects - 30 adults previously diagnosed with MetS randomly prescribed to one of three
groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no
exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes.
Intervention - 10-week diet with controlled glycemic indices provided for ketogenic group;
other groups maintained normal diet. Baseline triglyceride, HgA1c, VO2 max, body mass index
(BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were
assessed for all three groups at week 0 and week 3, 6 and 10.
Measures - ANOVA followed by tests pairwise differences using Tukey's HSD correction.
Analysis - Five of the seven variables for the ketogenic group showed a statistically
significant difference between week 0 and 10 data points.
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