N/A
N=30
Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies
Metabolic Syndrome · Diabetes Mellitus, Type 2 · Pre Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03047447 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Hemoglobin A1c — -.42; -0.37; 0.02 % of hemoglobin — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristlecone Behavioral Health, Inc.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
-.42; -0.37; 0.02 | 0.001 sig |
| SECONDARY Weight |
-28.40; -2.87; -2.43 | 0.001 sig |
| SECONDARY BMI (Body Mass Index) |
-4.4; -0.01; -0.42 | 0.001 sig |
| SECONDARY Body Fat Mass (Pounds of Body Fat) |
-0.03; -0.01; -0.00 | 0.001 sig |
| SECONDARY Ketones (Blood) |
0.24; 0.07; 0.04 | 0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Previously diagnosed with metabolic syndrome
Exclusion Criteria
- No diagnosis of metabolic syndrome
- < 18 years old
Data sourced from ClinicalTrials.gov (NCT03047447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.