Loading clinical trials...
Loading clinical trials...
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Bristlecone Behavioral Health, Inc.
Maple Grove, Minnesota, United States
Start Date
February 25, 2016
Primary Completion Date
September 30, 2016
Completion Date
November 30, 2016
Last Updated
April 25, 2017
30
ACTUAL participants
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome
BEHAVIORAL
Lead Sponsor
Bristlecone Behavioral Health, Inc.
Collaborators
NCT07237750
NCT07460856
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions