Clinical trial NCT03810378: Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
Official title: Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Keywords: Ketogenic diet
Mediterranean diet
Diabetes
Prediabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Microbiota composition
timeFrame: Baseline and 12 weeks
measure: Microbiota function
timeFrame: Baseline and 12 weeks
measure: LDL Cholesterol
timeFrame: Baseline and12 weeks
measure: HDL Cholesterol
timeFrame: Baseline and 12 weeks
measure: Triglycerides
timeFrame: Baseline and 12 weeks
measure: Fasting insulin
timeFrame: Baseline and 12 weeks
measure: Blood pressure
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Satisfaction with WFKD and Med-Plus diets
timeFrame: Baseline and 12 weeks
measure: Adherence to diet protocols
timeFrame: Baseline and 12 weeks
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Christopher Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.