Diabetes Mellitus, Type 2, Metabolic Syndrome, Pre Diabetes
Conditions
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.
Interventions
BEHAVIORALDietary 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
Sponsors
University of Minnesota
Bristlecone Behavioral Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Previously diagnosed with metabolic syndrome
Exclusion criteria
* No diagnosis of metabolic syndrome * \< 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 10-weeks | 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. |
| BMI (Body Mass Index) | 10-weeks | 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. |
| Body Fat Mass (Pounds of Body Fat) | 10-weeks | 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. |
| Ketones (Blood) | 10-weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| 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 | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Exercise Group | Non-exercise | Ketogenic Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Age, Continuous | 48.20 Age STANDARD_DEVIATION 9.77 | 50.20 Age STANDARD_DEVIATION 6.75 | 47.70 Age STANDARD_DEVIATION 9.51 | 48.70 Age STANDARD_DEVIATION 8.55 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 6 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Week 0 - Week 10
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketogenic Group | Hemoglobin A1c | -.42 % of hemoglobin |
| Exercise Group | Hemoglobin A1c | -0.37 % of hemoglobin |
| Non-exercise | Hemoglobin A1c | 0.02 % of hemoglobin |
p-value: 0.001ANOVA
Secondary
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.
Time frame: 10-weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketogenic Group | BMI (Body Mass Index) | -4.4 kg/m^2 |
| Exercise Group | BMI (Body Mass Index) | -0.01 kg/m^2 |
| Non-exercise | BMI (Body Mass Index) | -0.42 kg/m^2 |
p-value: 0.001ANOVA
Secondary
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.
Time frame: 10-weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketogenic Group | Body Fat Mass (Pounds of Body Fat) | -0.03 pounds |
| Exercise Group | Body Fat Mass (Pounds of Body Fat) | -0.01 pounds |
| Non-exercise | Body Fat Mass (Pounds of Body Fat) | -0.00 pounds |
p-value: 0.001ANOVA
Secondary
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.
Time frame: 10-weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketogenic Group | Ketones (Blood) | 0.24 mmol/L |
| Exercise Group | Ketones (Blood) | 0.07 mmol/L |
| Non-exercise | Ketones (Blood) | 0.04 mmol/L |
p-value: 0.001ANOVA
Secondary
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.
Time frame: 10-weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketogenic Group | Weight | -28.40 pounds |
| Exercise Group | Weight | -2.87 pounds |
| Non-exercise | Weight | -2.43 pounds |
p-value: 0.001ANOVA