NCT06571279

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Jean L. Fry · Academic / Other
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Plant-based diets that are abundant in myoinsitol and D-chiro inositol (MI and DCI) increase insulin sensitivity by promotion of insulin signaling lowering serum insulin and improving insulin resistance. The Western diet contributes to chronic metabolic inflammation often leading to the development of metabolic diseases. There is known metabolic improvement among men compared to women when following a plant-based diet or intensive lifestyle modifications. Through this study we look to identify the pathways in which plant-based diet impact skeletal muscle inositol metabolites among sexes (men vs. women) and improve insulin sensitivity.

Conditions

• Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Interventions

Type	Name	Description
OTHER	Plant-based diet	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.

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-11-25
• Completion: 2025-11-25
• First posted: 2024-08-26
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States