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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet (Med-Plus) | Experimental | Participants will follow a Mediterranean-type diet (Med-Plus) for 12 weeks. This diet will maximize the intake of vegetables, legumes, fruits and nuts, whole intact grains/cereals and fish; and minimize the intake of meat, poultry, and dairy. It will exclude added sugars and refined grains. |
|
| Well-Formulated Ketogenic Diet (WFKD) | Experimental | Participants will follow a Well-Formulated Ketogenic Diet (WFKD) for 12 weeks. This diet will maximize the intake of non-processed beef, pork, and poultry (preferably organic/grass-fed), fish, heavy cream, low-lactose, high-fat cheeses, animal fats, oils (avocado, coconut, or other nut oils), non-starchy (above ground) vegetables and limited amounts of some fruits (berries). It will exclude legumes, grains, sugars, starchy (below ground) vegetables, most fruits, and polyunsaturated oils (soy, sunflower, peanut, cottonseed, canola, etc.). It will aim for an intake of 20 g of carbohydrates/day at start, with the goal to have no more than 50 grams/day to maintain ketosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet (Med-Plus) | Behavioral | Participants will follow the Med-Plus diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Change from baseline in HbA1c at 12 weeks of each phase | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with WFKD and Med-Plus diets | 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). | Baseline and 12 weeks |
| Adherence to diet protocols |
Inclusion Criteria:
Identify exclusion criteria.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Gardner, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35641199 | Background | Gardner CD, Landry MJ, Perelman D, Petlura C, Durand LR, Aronica L, Crimarco A, Cunanan KM, Chang A, Dant CC, Robinson JL, Kim SH. Effect of a ketogenic diet versus Mediterranean diet on glycated hemoglobin in individuals with prediabetes and type 2 diabetes mellitus: The interventional Keto-Med randomized crossover trial. Am J Clin Nutr. 2022 Sep 2;116(3):640-652. doi: 10.1093/ajcn/nqac154. | |
| 33802709 |
| Label | URL |
|---|---|
| Study description and summary of results | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2020 | Jan 7, 2021 |
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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.
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| Well-Formulated Ketogenic Diet (WFKD) | Behavioral | Participants will follow the WFKD diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period). |
|
| Baseline and 12 weeks |
| Microbiota function | Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 12 weeks of each phase. | Baseline and 12 weeks |
| LDL Cholesterol | Change from baseline in LDL cholesterol at 12 weeks of each phase. | Baseline and12 weeks |
| HDL Cholesterol | Change from baseline in HDL cholesterol at 12 weeks of each phase. | Baseline and 12 weeks |
| Triglycerides | Change from baseline in triglycerides at 12 weeks of each phase. | Baseline and 12 weeks |
| Fasting insulin | Change from baseline in fasting insulin at 12 weeks of each phase. | Baseline and 12 weeks |
| Blood pressure | Change from baseline in blood pressure at 12 weeks of each phase. | 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. |
| Baseline and 12 weeks |
| Derived |
| Landry MJ, Crimarco A, Perelman D, Durand LR, Petlura C, Aronica L, Robinson JL, Kim SH, Gardner CD. Adherence to Ketogenic and Mediterranean Study Diets in a Crossover Trial: The Keto-Med Randomized Trial. Nutrients. 2021 Mar 17;13(3):967. doi: 10.3390/nu13030967. |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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