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

Primary Purpose

Metabolic Syndrome, Diabetes Mellitus, Type 2, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome
Sponsored by
Bristlecone Behavioral Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Previously diagnosed with metabolic syndrome

Exclusion Criteria:

  • No diagnosis of metabolic syndrome
  • < 18 years old

Sites / Locations

  • Bristlecone Behavioral Health, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Ketogenic group

Exercise group

Non-exercise

Arm Description

10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.

Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.

Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 7, 2017
Last Updated
April 24, 2017
Sponsor
Bristlecone Behavioral Health, Inc.
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03047447
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 25, 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristlecone Behavioral Health, Inc.
Collaborators
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes Mellitus, Type 2, Pre Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic group
Arm Type
Experimental
Arm Description
10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Arm Title
Non-exercise
Arm Type
Active Comparator
Arm Description
Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome
Intervention Description
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
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
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.
Time Frame
Week 0 - Week 10
Secondary Outcome Measure Information:
Title
Weight
Description
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.
Time Frame
10-weeks
Title
BMI (Body Mass Index)
Description
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.
Time Frame
10-weeks
Title
Body Fat Mass (Pounds of Body Fat)
Description
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.
Time Frame
10-weeks
Title
Ketones (Blood)
Description
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.
Time Frame
10-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Previously diagnosed with metabolic syndrome Exclusion Criteria: No diagnosis of metabolic syndrome < 18 years old
Facility Information:
Facility Name
Bristlecone Behavioral Health, Inc.
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55311
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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