Clinical trial NCT06571279: Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
Official title: Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin sensitivity (glucose infusion rate)
timeFrame: 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.
measure: Skeletal muscle d-chiroinositol content
timeFrame: 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:
measure: Phosphorylation status of insulin signaling molecules in skeletal muscle
timeFrame: 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.
measure: Absolute change in visceral fat (g)
timeFrame: 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.
measure: Fasting blood glucose
timeFrame: 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.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky CCTS
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jean L Fry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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