Mediterranean Diet and Blood Sugar Study

The Pennsylvania State University (PENNSTATE)

Status: Begins enrollment this month

Conditions: Prediabetes

Treatments: Other: Mediterranean-style diet with potatoes; Other: Traditional-style Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07229781

MDP

Details and patient eligibility

About

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.

Full description

This is a 12-week, 2-arm parallel, randomized controlled feeding trial. Participants will be randomized to either a Mediterranean-style diet that includes 1 medium potato/day/2000 kcal replacing some grains , or a traditional-style Mediterranean dietary pattern without potatoes. All food will be provided for the 12-week study duration.

Enrollment: 74 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Mediterranean-style diet with potato (MED-P)

Experimental group

Description:

Mediterranean-style diet that includes 1 medium potato/day/2000 kcal replacing some grains

Treatment:

Other: Mediterranean-style diet with potatoes

Traditional-style Mediterranean dietary pattern (MED)

Active Comparator group

Description:

A traditional-style Mediterranean diet that does not contain potatoes (potatoes are not a defining feature of this diet) and is higher in grains.

Treatment:

Other: Traditional-style Mediterranean diet