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Not yet recruiting NCT07229781

Mediterranean Diet and Blood Sugar Study

No phase Interventional Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mediterranean-style diet with potatoes, Traditional-style Mediterranean diet.
Who it may be relevant to
Registry conditions: Prediabetes. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Glycemic Effects of a Mediterranean-Style Dietary Pattern Containing Potatoes in Adults With Prediabetes

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Change in HbA1c [Time frame: 12-weeks]
Secondary outcome measures (12)
  • Change in fasting glucose [Time frame: 12-weeks]
  • Change in mean glucose [Time frame: 12-weeks]
  • Change in mean time in range [Time frame: 12-weeks]
  • Change in glycemic variability [Time frame: 12-weeks]
  • Change in fasting insulin [Time frame: 12-weeks]
  • Change in homeostatic model of insulin resistance (HOMA-IR) [Time frame: 12-weeks]
  • Change in LDL-Cholesterol [Time frame: 12-weeks]
  • Change in apolipoprotein B [Time frame: 12-weeks]
  • Change in non-HDL cholesterol [Time frame: 12-weeks]
  • Change in Total Cholesterol [Time frame: 12-weeks]
  • Change in HDL-Cholesterol [Time frame: 12-weeks]
  • Change in Triglycerides [Time frame: 12-weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07229781 · MDP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗