Assessing the Impact of a Plant-Based Diet for Diabetes Prevention

NCT06571279 | Completed DMC

• 1 other identifier: 95349
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity (glucose infusion rate)

  This gold standard test for IS will be performed at baseline and post-intervention with support of the COBRE Phenotyping core. After ≥8 hour fast, participants will be admitted to our Center for Clinical and Translational Science (CCTS) and two IVs inserted; one for infusion, the other for blood draws (see Phenotyping core). The primary outcome is the glucose infusion rate (GIR), a direct measure of whole body IS, which will enable us to detect even small changes in IS in response to the intervention. COBRE mentor Dr. Kern is proficient in use of these methods The primary clinical outcome is the change in GIR from post run-in to post intervention.

  The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.

• Skeletal muscle d-chiroinositol content

  Muscle samples will be homogenized, then inositol compounds will be extracted using solvents. In the prepared samples, D-chiroinositol content will be assessed by a commercial service using LC-MS/MS.

  The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.

Secondary Outcomes (3)

• Phosphorylation status of insulin signaling molecules in skeletal muscle

  The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.

• Absolute change in visceral fat (g)

  The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.

• Fasting blood glucose

  The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.

Study Arms (1)

Plant-based diet

OTHER

5 weeks of plant-based meals and snacks.

Other: Plant-based diet

Interventions

Plant-based diet OTHER

Standard plant-based meals will be provided directly to participants. The dietary intervention will begin with a one-week Western diet run-in; hereafter, participants will consume plant-based meals for approximately 5 weeks. Total energy provided will be equal to REE X 1.4 to account for light physical activity to support weight maintenance. High-inositol snacks will be provided to meet energy needs. Meals and snacks combined will provide a minimum of 20mg total inositol/kg body weight. For example, a 200lb participant will consume 1.8g daily, which is consistent with doses used in prior studies.

Plant-based diet

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: Since sex hormones may play a role in diet response, prospective participants taking a medication that significantly affects sex hormones (like estrogen or testosterone) will not be eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index greater than or equal to 27
• High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
• Prediabetes (based on fasting glucose 100-125 mg/dL, HbA1c 5.7-6.4, or 2-hr post-oral glucose tolerance test glucose screen between 140-199mg/dL)
• Physical activity below national guidelines
• Aged 30-55 (premenopausal for women)
• Following a Western diet

You may not qualify if:

• Diabetes diagnosis
• Take medications that may affect insulin sensitivity
• More than 5% weight change within 6 months of screening
• History of bariatric surgery
• Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
• Take hormone replacement therapy
• Consume 3 or more servings of combined fruit and vegetables daily and/or 3 or more servings of whole grains daily
• Any food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0 or allergy to lidocaine

Sponsors & Collaborators

• Jean L. Fry: lead

Study Sites (1)

University of Kentucky CCTS

Lexington, Kentucky, 40536, United States

Location

Related Publications (10)

• Bedard A, Riverin M, Dodin S, Corneau L, Lemieux S. Sex differences in the impact of the Mediterranean diet on cardiovascular risk profile. Br J Nutr. 2012 Oct 28;108(8):1428-34. doi: 10.1017/S0007114511006969. Epub 2012 Jan 6.

  PMID: 22221517 BACKGROUND

• Chen Z, Zuurmond MG, van der Schaft N, Nano J, Wijnhoven HAH, Ikram MA, Franco OH, Voortman T. Plant versus animal based diets and insulin resistance, prediabetes and type 2 diabetes: the Rotterdam Study. Eur J Epidemiol. 2018 Sep;33(9):883-893. doi: 10.1007/s10654-018-0414-8. Epub 2018 Jun 8.

  PMID: 29948369 BACKGROUND

• Perreault L, Ma Y, Dagogo-Jack S, Horton E, Marrero D, Crandall J, Barrett-Connor E; Diabetes Prevention Program. Sex differences in diabetes risk and the effect of intensive lifestyle modification in the Diabetes Prevention Program. Diabetes Care. 2008 Jul;31(7):1416-21. doi: 10.2337/dc07-2390. Epub 2008 Mar 20.

  PMID: 18356403 BACKGROUND

• Leblanc V, Begin C, Hudon AM, Royer MM, Corneau L, Dodin S, Lemieux S. Gender differences in the long-term effects of a nutritional intervention program promoting the Mediterranean diet: changes in dietary intakes, eating behaviors, anthropometric and metabolic variables. Nutr J. 2014 Nov 22;13:107. doi: 10.1186/1475-2891-13-107.

  PMID: 25416917 BACKGROUND

• Sargrad KR, Homko C, Mozzoli M, Boden G. Effect of high protein vs high carbohydrate intake on insulin sensitivity, body weight, hemoglobin A1c, and blood pressure in patients with type 2 diabetes mellitus. J Am Diet Assoc. 2005 Apr;105(4):573-80. doi: 10.1016/j.jada.2005.01.009.

  PMID: 15800559 BACKGROUND

• Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.

  PMID: 24595221 BACKGROUND

• Minambres I, Cuixart G, Goncalves A, Corcoy R. Effects of inositol on glucose homeostasis: Systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1146-1152. doi: 10.1016/j.clnu.2018.06.957. Epub 2018 Jun 21.

  PMID: 29980312 BACKGROUND

• Soldevila-Domenech N, Pastor A, Sala-Vila A, Lazaro I, Boronat A, Munoz D, Castaner O, Fagundo B, Corella D, Fernandez-Aranda F, Martinez-Gonzalez MA, Salas-Salvado J, Fito M, de la Torre R. Sex differences in endocannabinoids during 3 years of Mediterranean diet intervention: Association with insulin resistance and weight loss in a population with metabolic syndrome. Front Nutr. 2022 Dec 1;9:1076677. doi: 10.3389/fnut.2022.1076677. eCollection 2022.

  PMID: 36532543 BACKGROUND

• Brennan L, Gibbons H. Sex matters: a focus on the impact of biological sex on metabolomic profiles and dietary interventions. Proc Nutr Soc. 2020 May;79(2):205-209. doi: 10.1017/S002966511900106X. Epub 2019 Jul 31.

  PMID: 31362802 BACKGROUND

• Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.

  PMID: 20811656 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jean L Fry, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor- PI

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 14, 2024
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)