RECRUITING Not applicable ClinicalTrials.gov

Mediterranean Diet and Blood Sugar Study

Sponsor: Penn State University • ClinicalTrials.gov ID: NCT07229781

Registry updated: 2026-10-05

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Mediterranean-style diet with potatoes (Other)
The diet will contain 1 medium potato/day/2000 kcal
Traditional-style Mediterranean diet (Other)
Traditional-style Mediterranean diet higher in grains

Eligibility criteria

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

Conditions

Prediabetes

Locations

The Pennsylvania State University — University Park, Pennsylvania, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment