An interventional study of Mediterranean Diet (Med-Plus) and Well-Formulated Ketogenic Diet (WFKD) in Diabetes Mellitus, Type 2 and PreDiabetes, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Identify exclusion criteria.
Exclusion Criteria:
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.
Behavioral: Mediterranean Diet (Med-Plus)
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.
Behavioral: Well-Formulated Ketogenic Diet (WFKD)
Participants will follow the Med-Plus diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).
Participants will follow the WFKD diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).
Hemoglobin A1c (HbA1c)
Change from baseline in HbA1c at 12 weeks of each phase
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
Time frame: Baseline and 12 weeks
LDL Cholesterol
Change from baseline in LDL cholesterol at 12 weeks of each phase.
Time frame: Baseline and12 weeks
HDL Cholesterol
Change from baseline in HDL cholesterol at 12 weeks of each phase.
Time frame: Baseline and 12 weeks
Triglycerides
Change from baseline in triglycerides at 12 weeks of each phase.
Time frame: Baseline and 12 weeks
Fasting insulin
Change from baseline in fasting insulin at 12 weeks of each phase.
Time frame: Baseline and 12 weeks
Blood pressure
Change from baseline in blood pressure at 12 weeks of each phase.
Time frame: Baseline and 12 weeks
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).
Time frame: Baseline and 12 weeks
Adherence to diet protocols
Adherence to diet protocols 12 weeks of each phase in subjects with Diabetes compared to subjects with prediabetes, according to 3-day food records.
Time frame: Baseline and 12 weeks
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Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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