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

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ClinicalTrials.gov Identifier: NCT03810378
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Gardner, Stanford University

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE March 21, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and 12 weeks ]
Change from baseline in HbA1c at 12 weeks of each phase
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Microbiota composition [ Time Frame: Baseline and 12 weeks ]
    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.
  • Microbiota function [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 12 weeks of each phase.
  • LDL Cholesterol [ Time Frame: Baseline and12 weeks ]
    Change from baseline in LDL cholesterol at 12 weeks of each phase.
  • HDL Cholesterol [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in HDL cholesterol at 12 weeks of each phase.
  • Triglycerides [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in triglycerides at 12 weeks of each phase.
  • Fasting insulin [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in fasting insulin at 12 weeks of each phase.
  • Blood pressure [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in blood pressure at 12 weeks of each phase.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 17, 2019)
  • Satisfaction with WFKD and Med-Plus diets [ Time Frame: Baseline and 12 weeks ]
    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).
  • Adherence to diet protocols [ Time Frame: Baseline and 12 weeks ]
    Adherence to diet protocols 12 weeks of each phase in subjects with Diabetes compared to subjects with prediabetes, according to 3-day food records.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
Official Title  ICMJE Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • PreDiabetes
Intervention  ICMJE
  • 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).
  • Behavioral: 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).
Study Arms  ICMJE
  • Experimental: Mediterranean Diet (Med-Plus)
    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.
    Intervention: Behavioral: Mediterranean Diet (Med-Plus)
  • Experimental: Well-Formulated Ketogenic Diet (WFKD)
    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.
    Intervention: Behavioral: Well-Formulated Ketogenic Diet (WFKD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18
  • Diagnosed with type 2 diabetes mellitus, on oral anti-T2DM medications only (stable dose for 3 months)

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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Robinson, PhD 650-736-8577 jlmorris@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810378
Other Study ID Numbers  ICMJE 49218
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Gardner, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Gardner, PhD Stanford University
PRS Account Stanford University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP