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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome, Diabetes Mellitus, Type 2, Pre Diabetes

Intervention / Treatment
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* Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously diagnosed with metabolic syndrome Exclusion Criteria: No diagnosis of metabolic syndrome < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic group<br>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. | Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome<br>* 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<br>|
| Active Comparator: Exercise group<br>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. | Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome<br>* 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<br>|
| Active Comparator: Non-exercise<br>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. | Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |