Mediterranean Diet and Blood Sugar Study

Starting soon · Not applicable

Conditions studied: Prediabetes

In brief

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

Key facts

Study ID

NCT07229781

Run by

Penn State University

People needed

74

Starts

2026-08-01

Expected to finish

2028-04-30

Last updated by the study team

2026-07-15

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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