Metabolic SyndromeNCT03047447
Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies
A study testing Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome in people with Metabolic Syndrome and Diabetes Mellitus, Type 2, run by Bristlecone Behavioral Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Pre Diabetes
- What is being tested?
- Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previously diagnosed with metabolic syndrome
Who cannot join
- No diagnosis of metabolic syndrome
- < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristlecone Behavioral Health, Inc.
Maple Grove, Minnesota, 55311
About this study
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.
Read the 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
- Being tested
- Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Ketosis: Regulator of Obesity and Metabolic SyndromeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 - Week 10
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start25 Feb 2016
- Primary completion30 Sep 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristlecone Behavioral Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047447
- Sponsor's protocol ID
- Bristlecone Health
- Status last verified
- Apr 2017
- First submitted
- 7 Feb 2017
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome Pathologies
- ClinicalTrials.gov ID
- NCT03047447
- Acronym / sponsor ID
- Bristlecone Health
- Conditions
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristlecone Behavioral Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketogenic group | Experimental | Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome10-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 | Active comparator | Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic SyndromeExercise 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 | Active comparator | Behavioral: Dietary Ketosis: Regulator of Obesity and Metabolic SyndromeNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Previously diagnosed with metabolic syndrome
Key exclusion criteria (2 listed)
- No diagnosis of metabolic syndrome
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome30 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 | Behavioural | Exercise group, Ketogenic group, Non-exercise |
Primary outcome
Hemoglobin A1c
Time frame: Week 0 - Week 10
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.
4 secondary outcomes
Weight
Time frame: 10-weeks
BMI (Body Mass Index)
Time frame: 10-weeks
Body Fat Mass (Pounds of Body Fat)
Time frame: 10-weeks
Ketones (Blood)
Time frame: 10-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome in people with Metabolic Syndrome and Diabetes Mellitus, Type 2, run by Bristlecone Behavioral Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Week 0 - Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.