Clinical trial NCT03047447: Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies
Official title: Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Diabetes Mellitus, Type 2
Pre Diabetes
Lead sponsor: Bristlecone Behavioral Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
First posted: 2017-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with metabolic syndrome

Exclusion Criteria:

* No diagnosis of metabolic syndrome
* \< 18 years old

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Week 0 - Week 10
Secondary outcomes:
measure: Weight
timeFrame: 10-weeks
measure: BMI (Body Mass Index)
timeFrame: 10-weeks
measure: Body Fat Mass (Pounds of Body Fat)
timeFrame: 10-weeks
measure: Ketones (Blood)
timeFrame: 10-weeks
Other outcomes:
Locations:
city: Maple Grove
country: United States
facility: Bristlecone Behavioral Health, Inc.
state: Minnesota
Study officials:
References: