Mediterranean Diet With or Without Potatoes in Adults with Prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 12-week, two-arm randomized controlled feeding trial. Participants will be assigned to either a Mediterranean-style diet that includes one medium potato per day or a traditional Mediterranean diet without potatoes, with all meals provided. The study aims to compare effects on risk factors for type 2 diabetes and cardiovascular disease. Assessments occur at the start and end of the intervention. The trial is conducted at Penn State University with collaboration from the Alliance for Potato Research and Education.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 25-65 years
* Prediabetes assessed by an HbA1c of 5.7-6.4% or fasting glucose 100-125 mg/dL at screening
* BMI 25-40 kg/m2 at screening

Exclusion Criteria:

* HbA1c ≥6.5% at screening
* LDL-C (calculated with the Martin-Hopkins equation) ≥190 mg/dL at screening
* Hemoglobin \<13.2 g/dL at screening
* Fasting triglycerides \>350 mg/dL at screening

  -≥10% change in body weight within the 6 months prior to enrollment
* Blood pressure \>140/90 mmHg at screening
* Type 1 or type 2 diabetes
* Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs
* Intake of supplements that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the study period.
* History of liver, kidney, or autoimmune disease
* Prior cardiovascular event (e.g., stroke, heart attack)
* Current pregnancy or intention of pregnancy within the next 6 months
* Lactation within the prior 6 months
* Allergy/intolerance/sensitivity/dislike of any foods in the study menus
* Antibiotic use within the prior 1 month
* Oral steroid use within the prior 1 month
* Use of tobacco or nicotine-containing products within the past 6 months
* History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
* Participation in another clinical trial within 60 days of baseline
* Currently following a restricted or weight-loss diet
* Prior bariatric surgery
* Intake of \>14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
* Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
* Does not speak and/or understand English
* Unwilling to refrain from donating blood during the study
* Weight \<110 lb

Where it's running

• The Pennsylvania State University
  University Park, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Kristina Petersen, PhD
• Email: kup63@psu.edu
• Phone: 814-865-7206

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.