Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047447
• Other study ID #: Bristlecone Health
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: April 24, 2017
• Start date: February 25, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: April 2017
• Source: Bristlecone Behavioral Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously diagnosed with metabolic syndrome

Exclusion Criteria:

• No diagnosis of metabolic syndrome

• < 18 years old

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Pre Diabetes
• Prediabetic State
• Syndrome

Intervention

Behavioral:
• Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome
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

Locations

Country	Name	City	State
United States	Bristlecone Behavioral Health, Inc.	Maple Grove	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Bristlecone Behavioral Health, Inc.	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Hemoglobin A1c (HgA1c) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for HgA1c at week 10 minus the HgA1c value at week 0.	Week 0 - Week 10
Secondary	Weight	Weight was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for weight at week 10 minus weight at week 0.	10-weeks
Secondary	BMI (Body Mass Index)	BMI (body mass index) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BMI at week 10 minus BMI at week 0.	10-weeks
Secondary	Body Fat Mass (Pounds of Body Fat)	BFM (body fat mass) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BFM at week 10 minus BFM at week 0.	10-weeks
Secondary	Ketones (Blood)	Ketones (blood) were measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for ketones (blood) at week 10 minus ketones (blood) at week 0.	10-weeks