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

NCT ID: NCT03047447

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-25
• Study Completion Date: 2016-11-30

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.

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Pre Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketogenic group

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.

Group Type: EXPERIMENTAL

Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome

Intervention Type: BEHAVIORAL

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

Exercise group

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.

Group Type: ACTIVE_COMPARATOR

Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome

Intervention Type: BEHAVIORAL

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

Non-exercise

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.

Group Type: ACTIVE_COMPARATOR

Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Previously diagnosed with metabolic syndrome

Exclusion Criteria

• No diagnosis of metabolic syndrome
• < 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Bristlecone Behavioral Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bristlecone Behavioral Health, Inc.

Maple Grove, Minnesota, United States

Countries

United States

Other Identifiers

Bristlecone Health

Identifier Type: -

Identifier Source: org_study_id