Diabetes Mellitus, Type 2, PreDiabetes
Conditions
Keywords
Ketogenic diet, Mediterranean diet, Diabetes, Prediabetes
Brief summary
The objective of this study is to compare two metabolically distinct diets, WFKD vs Med-Plus, in order to examine the potential benefits, and unintended consequences, of going beyond a focus on maximally avoiding added sugars and refined grains, to also avoiding legumes, fruits, and whole grains.
Detailed description
The proposed randomized clinical trial will investigate differential population-specific effects of two low-carbohydrate (low-carb) diet patterns, addressing a gap in the evidence base in this area that will lead to 1) improved treatment strategies for common adverse clinical conditions, 2) improved health for these individuals, and 3) long-term decreases in health care costs. This impactful research will advance the field of personalized and precision medicine.
Interventions
BEHAVIORALMediterranean Diet (Med-Plus)
Participants will follow the Med-Plus diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).
BEHAVIORALWell-Formulated Ketogenic Diet (WFKD)
Participants will follow the WFKD diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
40 adults will be randomized in cross-over design to a Ketogenic or Mediterranean diet for 12 weeks each (no washout) with a 1 month follow-up at the end of the second phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 * Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c \</= 5.7% OR Fasting Glucose of \>100 mg/dL) Identify
Exclusion criteria
. * Weight \< 110 lb * BMI \> 40 * LDL-C \>190 mg/dL * Blood pressure: SBP \> 160 mmHg OR DBP: \> 90 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Baseline and 12 weeks | Change from baseline in HbA1c at 12 weeks of each phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota composition | Baseline and 12 weeks | Change from baseline in alpha diversity at 12 weeks of each phase. We will be using number of observed sequence variants (species) determined by standard 16S rRNA amplicon sequencing (V3-V5 region followed by DADA2 to define error-corrected sequence variants) as our primary metric of alpha diversity. Higher alpha diversity is better. The units are the # of sequence variants. |
| Microbiota function | Baseline and 12 weeks | Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 12 weeks of each phase. |
| LDL Cholesterol | Baseline and12 weeks | Change from baseline in LDL cholesterol at 12 weeks of each phase. |
| HDL Cholesterol | Baseline and 12 weeks | Change from baseline in HDL cholesterol at 12 weeks of each phase. |
| Fasting insulin | Baseline and 12 weeks | Change from baseline in fasting insulin at 12 weeks of each phase. |
| Blood pressure | Baseline and 12 weeks | Change from baseline in blood pressure at 12 weeks of each phase. |
| Triglycerides | Baseline and 12 weeks | Change from baseline in triglycerides at 12 weeks of each phase. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with WFKD and Med-Plus diets | Baseline and 12 weeks | Average satisfaction level with meals at 12 weeks of each phase (WFKD compared to Med-Plus phase) using a 5-point Likert scale (1=not at all satisfied; 2=slightly satisfied; 3=moderately satisfied; 4=very satisfied; 5=extremely satisfied). |
| Adherence to diet protocols | Baseline and 12 weeks | Adherence to diet protocols 12 weeks of each phase in subjects with Diabetes compared to subjects with prediabetes, according to 3-day food records. |
Countries
United States
Outcome results
None listed