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Diabetes Mellitus, Type 2NCT03810378

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

A study testing Mediterranean Diet (Med-Plus) and Well-Formulated Ketogenic Diet (WFKD) in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2, PreDiabetes
What is being tested?
Mediterranean Diet (Med-Plus) and Well-Formulated Ketogenic Diet (WFKD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
5 Jun 2019to 6 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Being tested
Mediterranean Diet (Med-Plus), Well-Formulated Ketogenic Diet (WFKD)
Keywords
Ketogenic diet, Mediterranean diet, Diabetes, Prediabetes
Medical subject headings
Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean Diet (Med-Plus)Behavioural

    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)Behavioural

    Participants will follow the WFKD diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).

Study groups in NCT03810378
Study groupRoleWhat they receive
Mediterranean Diet (Med-Plus)ExperimentalParticipants 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.
Receives: Behavioral: Mediterranean Diet (Med-Plus)
Well-Formulated Ketogenic Diet (WFKD)ExperimentalParticipants 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.
Receives: Behavioral: Well-Formulated Ketogenic Diet (WFKD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c (HbA1c)

    Change from baseline in HbA1c at 12 weeks of each phase

    Measured: Baseline and 12 weeks

Secondary outcomes (7)

  1. 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.

    Measured: Baseline and 12 weeks

  2. 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.

    Measured: Baseline and 12 weeks

  3. LDL Cholesterol

    Change from baseline in LDL cholesterol at 12 weeks of each phase.

    Measured: Baseline and12 weeks

  4. HDL Cholesterol

    Change from baseline in HDL cholesterol at 12 weeks of each phase.

    Measured: Baseline and 12 weeks

  5. Triglycerides

    Change from baseline in triglycerides at 12 weeks of each phase.

    Measured: Baseline and 12 weeks

  6. Fasting insulin

    Change from baseline in fasting insulin at 12 weeks of each phase.

    Measured: Baseline and 12 weeks

  7. Blood pressure

    Change from baseline in blood pressure at 12 weeks of each phase.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start5 Jun 2019
  3. Primary completion4 Dec 2020
  4. Study completion6 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03810378
Sponsor's protocol ID
49218
Status last verified
Feb 2023
First submitted
9 Jan 2019
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35641199

  • 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.

    PubMed 33802709

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean Diet (Med-Plus) and Well-Formulated Ketogenic Diet (WFKD) in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c (HbA1c) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03810378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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