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

NCT03810378 | Completed DMC

• 1 other identifier: 49218
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; PreDiabetes

Keywords

Ketogenic diet; Mediterranean diet; Diabetes; Prediabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c)

  Change from baseline in HbA1c at 12 weeks of each phase

  Baseline and 12 weeks

Secondary Outcomes (7)

• Microbiota composition

  Baseline and 12 weeks

• Microbiota function

  Baseline and 12 weeks

• LDL Cholesterol

  Baseline and12 weeks

• HDL Cholesterol

  Baseline and 12 weeks

• Triglycerides

  Baseline and 12 weeks

Other Outcomes (2)

• Satisfaction with WFKD and Med-Plus diets

  Baseline and 12 weeks

• Adherence to diet protocols

  Baseline and 12 weeks

Study Arms (2)

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.

Behavioral: Mediterranean Diet (Med-Plus)

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.

Behavioral: Well-Formulated Ketogenic Diet (WFKD)

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).

Mediterranean Diet (Med-Plus)

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).

Well-Formulated Ketogenic Diet (WFKD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c \</= 5.7% OR Fasting Glucose of \>100 mg/dL)

You may not qualify if:

• Weight \< 110 lb
• BMI \> 40
• LDL-C \>190 mg/dL
• Blood pressure: SBP \> 160 mmHg OR DBP: \> 90 mmHg
• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 35641199 BACKGROUND

• 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.

  PMID: 33802709 DERIVED

Related Links

• Study description and summary of results

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Diabetes Mellitus

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Christopher Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 18, 2019
• Study Start: June 5, 2019
• Primary Completion: December 4, 2020
• Study Completion: December 6, 2020
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)