NCT03047447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

February 7, 2017

Results QC Date

February 13, 2017

Last Update Submit

April 24, 2017

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2Pre Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Weight

    10-weeks

  • BMI (Body Mass Index)

    10-weeks

  • Body Fat Mass (Pounds of Body Fat)

    10-weeks

  • Ketones (Blood)

    10-weeks

Study Arms (3)

Ketogenic group

EXPERIMENTAL

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

Exercise group

ACTIVE COMPARATOR

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

Non-exercise

ACTIVE COMPARATOR

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

Interventions

Dietary Ketosis: Regulator of Obesity and Metabolic SyndromeBEHAVIORAL

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 groupKetogenic groupNon-exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously diagnosed with metabolic syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristlecone Behavioral Health, Inc.

Maple Grove, Minnesota, 55311, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2Glucose Intolerance

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesHyperglycemia

Results Point of Contact

Title
Dr. Kelly Gibas, Director or Clinical Trials
Organization
Bristlecone Health, Inc,
kgibas@bristleconefitness.com
(763) 424-2474

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

February 25, 2016

Primary Completion

September 30, 2016

Study Completion

November 30, 2016

Last Updated

April 25, 2017

Results First Posted

April 25, 2017

Record last verified: 2017-04

Locations

US(1)