Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial

Stanford University61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2 PreDiabetes

Interventions

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).

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: * Weight \< 110 lb * BMI ≥ 40 * LDL-C \>190 mg/dL * Systolic blood pressure (SBP) \> 160 mmHg OR Diastolic blood pressure (DBP) \> 90 mmHg * Diagnosed with type 1 diabetes or history of ketoacidosis * Uncontrolled and untreated diabetes (by discretion of study physician) * Active cardiovascular disease (in past year with myocardial infarction, coronary stent or bypass surgery) * Kidney disease (eGFR less than 50 mL/min per 1.73 m2) * Liver disease (liver transaminase higher than 3 times the normal range for the laboratory) * Symptomatic gallstones * History of bariatric surgery * Anemia * Taking any of the following medications in past 3 months: SGLT-2 inhibitors, GLP-1 receptor agonist, Insulin, Amylin analog, Alpha-glucosidase inhibitor, Dopamine agonist, Bile acid sequestrant. * Taking any medications for weight loss * History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision * Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet. * Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or \> 14 drinks/week. * Women: Pregnant currently or planning to become pregnant during the course of the study, and/or breastfeeding * Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products * Regular use of prescription opiate pain medication

Locations (1)

Stanford University

Stanford, California, United States