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

Jean L. Fry

Status: Completed

Conditions: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Treatments: Other: Plant-based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06571279

95349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Plant-based diet

Other group

Description:

5 weeks of plant-based meals and snacks.

Treatment:

Other: Plant-based diet