Vegetarian Ketogenic Diet VS Omnivore Ketogenic Diet - Protocol of a Keto-vege Diet for Remission of Type 2 Diabetes

NCT05579561 | Unknown DMC

• 1 other identifier: DT2-OFF
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is one of the biggest public health challenges of the 21st century because of the costs associated with its management, which are estimated at more than three billion dollars per year in Quebec. This cost has been growing steadily for 20 years now. A person with controlled diabetes mobilizes three times more medical resources than a person without diabetes (Diabetes Quebec, 2009). This amount increases rapidly with the associated complications. Therapeutic carbohydrate restriction (in an omnivorous context) used specifically to control glycemia is being studied more and more, but has never been verified in a vegan context. Some studies show that a vegan diet could be an effective way to help type 2 diabetics (T2DM) to better manage their blood sugar. Thus, it is necessary to question whether these effects can be accentuated in the context of a low or very low carbohydrate diet. Numerous publications have highlighted the role of the gut microbiota in metabolic diseases, including T2DM. Analysis of the microbiome before and after dietary change combined with daily breath testing will tell us more about possible intolerances and the role of the microbiome in T2DM management. Given the novelty of these hypotheses and its absence in the literature, it is relevant to undertake a first pilot project with a smaller number of participants in order to obtain preliminary data that will allow us to define more precisely the research avenues for a subsequent study.

Conditions

Diabetes Mellitus Type 2 in Obese; Hypertension; Diabetes Mellitus Type 2 With Hyperglycemia; Inflammation; Dysbiosis

Keywords

Diabetes Mellitus Type 2; Hyperglycemia; Inflammation; Dysbiosis; Obesity; ketogenic diet; carbs restriction

Outcome Measures

Primary Outcomes (4)

• Change from baseline HbA1c

  Complete blood workup including the HbA1c , are done at the beginning and at the end of the 6 months to measure the improvement of glycated hemoglobin

  Baseline and week 26

• Change from baseline CRP

  Complete blood workup including the C reactive protein , are done at the beginning and at the end of the 6 months to measure the improvement of the CRP

  Baseline and week 26

• Change from baseline of fasting insulin

  Complete blood workup including the 14 hours fasting insulin , are done at the beginning and at the end of the 6 months to measure the improvement of insulinemia

  Baseline and week 26

• Change from baseline of triglycerides

  Complete blood workup including triglycerides , are done at the beginning and at the end of the 6 months to measure the improvement of the lipid profil

  Baseline and week 26

Secondary Outcomes (2)

• Change in the digestive gaz exhale after meal

  90 min after each meal, during the first 2 months and the last 2 months

• Change in the microbiome

  Baseline and week 26

Study Arms (2)

Vegetarian ketogenic diet

EXPERIMENTAL

Participants will be required to eat a diet that is very low in carbohydrates, moderate in vegetarian proteins, including fish and eggs, with added healthy fats

Other: Diet

Omnivor ketogenic diet

ACTIVE COMPARATOR

Participants will be required to eat a diet that is very low in carbohydrates, moderate in animal protein, with added healthy fats.

Other: Diet

Interventions

Diet OTHER

Participants, in both groups, will be required to eat a diet that is very low in carbohydrates, moderate in protein, with added healthy fats. They will also have to breath in the device to estimate the level of different exhale gaz.

Also known as: Device

Omnivor ketogenic diet; Vegetarian ketogenic diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Under medication to treat type 2 diabetes
• Aged ≥ 18 years through 70 years

You may not qualify if:

• Type 1 diabetes
• Aged \<18 years or \>70 years
• Abnormal or low blood C-peptide by standard laboratory measurements.
• Have already initiated the change to ketogenic or vegan diet for more than 1 month.
• Pregnant or breastfeeding women

Sponsors & Collaborators

• BloomedIn: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

Elna Clinic

Saint-Mathieu, Quebec, J3G0R2, Canada

Location

Related Publications (9)

• Diabetes Canada Position Statement on Low-Carbohydrate Diets for Adults With Diabetes: A Rapid Review. Can J Diabetes. 2020 Jun;44(4):295-299. doi: 10.1016/j.jcjd.2020.04.001. Epub 2020 Apr 24. No abstract available.

  PMID: 32475469 BACKGROUND

• Goldenberg JZ, Day A, Brinkworth GD, Sato J, Yamada S, Jonsson T, Beardsley J, Johnson JA, Thabane L, Johnston BC. Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data. BMJ. 2021 Jan 13;372:m4743. doi: 10.1136/bmj.m4743.

  PMID: 33441384 BACKGROUND

• Gurung M, Li Z, You H, Rodrigues R, Jump DB, Morgun A, Shulzhenko N. Role of gut microbiota in type 2 diabetes pathophysiology. EBioMedicine. 2020 Jan;51:102590. doi: 10.1016/j.ebiom.2019.11.051. Epub 2020 Jan 3.

  PMID: 31901868 BACKGROUND

• Khazrai YM, Defeudis G, Pozzilli P. Effect of diet on type 2 diabetes mellitus: a review. Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:24-33. doi: 10.1002/dmrr.2515.

  PMID: 24352832 BACKGROUND

• Rezaie A, Buresi M, Lembo A, Lin H, McCallum R, Rao S, Schmulson M, Valdovinos M, Zakko S, Pimentel M. Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus. Am J Gastroenterol. 2017 May;112(5):775-784. doi: 10.1038/ajg.2017.46. Epub 2017 Mar 21.

  PMID: 28323273 BACKGROUND

• Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.

  PMID: 31231311 RESULT

• Lin CL, Huang LC, Chang YT, Chen RY, Yang SH. Effectiveness of Health Coaching in Diabetes Control and Lifestyle Improvement: A Randomized-Controlled Trial. Nutrients. 2021 Oct 29;13(11):3878. doi: 10.3390/nu13113878.

  PMID: 34836135 RESULT

• Kahleova H, Matoulek M, Malinska H, Oliyarnik O, Kazdova L, Neskudla T, Skoch A, Hajek M, Hill M, Kahle M, Pelikanova T. Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet Med. 2011 May;28(5):549-59. doi: 10.1111/j.1464-5491.2010.03209.x.

  PMID: 21480966 RESULT

• Wang LL, Wang Q, Hong Y, Ojo O, Jiang Q, Hou YY, Huang YH, Wang XH. The Effect of Low-Carbohydrate Diet on Glycemic Control in Patients with Type 2 Diabetes Mellitus. Nutrients. 2018 May 23;10(6):661. doi: 10.3390/nu10060661.

  PMID: 29882884 RESULT

MeSH Terms

Conditions

Hypertension; Inflammation; Dysbiosis; Diabetes Mellitus, Type 2; Hyperglycemia; Obesity

Interventions

Diet; Equipment and Supplies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Andre Marette

  Institut universitaire de cardiologie et de pneumologie de Quebec

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In a clinical study pilot project, compare vegetarian therapeutic carbohydrates restriction to the omnivore version, in the contexte of reverse type 2 diabetes symptoms

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: May 11, 2022
• Primary Completion: November 11, 2022
• Study Completion: December 30, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

CA (1)