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

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ClinicalTrials.gov Identifier: NCT03047447
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Metabolic Syndrome
Diabetes Mellitus, Type 2
Pre Diabetes
Intervention: Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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

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.

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

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.

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


Participant Flow:   Overall Study
    Ketogenic Group   Exercise Group   Non-exercise
STARTED   10   10   10 
COMPLETED   10   10   10 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

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.

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

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.

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

Total Total of all reporting groups

Baseline Measures
   Ketogenic Group   Exercise Group   Non-exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Age 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   10   10   30 
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      10 100.0%      10 100.0%      30 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Age]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 10   10   10   30 
   47.70  (9.51)   48.20  (9.77)   50.20  (6.75)   48.70  (8.55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Female      6  60.0%      10 100.0%      10 100.0%      26  86.7% 
Male      4  40.0%      0   0.0%      0   0.0%      4  13.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 0   0   0   0 
            0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
       
United States         
Participants Analyzed 
[Units: Participants]
 10   10   10   30 
United States   10   10   10   30 


  Outcome Measures

1.  Primary:   Hemoglobin A1c   [ Time Frame: Week 0 - Week 10 ]

2.  Secondary:   Weight   [ Time Frame: 10-weeks ]

3.  Secondary:   BMI (Body Mass Index)   [ Time Frame: 10-weeks ]

4.  Secondary:   Body Fat Mass (Pounds of Body Fat)   [ Time Frame: 10-weeks ]

5.  Secondary:   Ketones (Blood)   [ Time Frame: 10-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kelly Gibas, Director or Clinical Trials
Organization: Bristlecone Health, Inc,
phone: (763) 424-2474
e-mail: kgibas@bristleconefitness.com



Responsible Party: Bristlecone Behavioral Health, Inc.
ClinicalTrials.gov Identifier: NCT03047447     History of Changes
Other Study ID Numbers: Bristlecone Health
First Submitted: February 7, 2017
First Posted: February 9, 2017
Results First Submitted: February 13, 2017
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017