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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810378
• Other study ID #: 49218
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: December 6, 2020

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 6, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Mediterranean Diet (Med-Plus)
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)
Participants will follow the WFKD diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum In: Am J Clin Nutr. 2022 Dec 19;116(6):1904. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	Baseline and 12 weeks
Primary	Hemoglobin A1c (HbA1c)	Change from baseline in HbA1c at 12 weeks of each phase	Baseline and 12 weeks
Secondary	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.	Baseline and 12 weeks
Secondary	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
Secondary	LDL Cholesterol	Change from baseline in LDL cholesterol at 12 weeks of each phase.	Baseline and12 weeks
Secondary	HDL Cholesterol	Change from baseline in HDL cholesterol at 12 weeks of each phase.	Baseline and 12 weeks
Secondary	Triglycerides	Change from baseline in triglycerides at 12 weeks of each phase.	Baseline and 12 weeks
Secondary	Fasting insulin	Change from baseline in fasting insulin at 12 weeks of each phase.	Baseline and 12 weeks
Secondary	Blood pressure	Change from baseline in blood pressure at 12 weeks of each phase.	Baseline and 12 weeks

External Links

•   Study description and summary of results