Mediterranean Diet and Blood Sugar Study

N/ANot Yet RecruitingNCT07229781

Penn State University74 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Prediabetes

Interventions

Mediterranean-style diet with potatoesOTHER

The diet will contain 1 medium potato/day/2000 kcal

Traditional-style Mediterranean dietOTHER

Traditional-style Mediterranean diet higher in grains

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in HbA1c

HbA1c will be assessed at baseline and 12-weeks and expressed as percentage . The change in HbA1c will be calculated by subtracting the baseline value from the 12 week value and expressed as percentage point change.

Time frame: 12-weeks

Secondary Outcomes

Change in fasting glucose

Change in fasting plasma glucose expressed as mg/dL. Change in glucose will be calculated as the mean of the 12 week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).

Time frame: 12-weeks

Change in mean glucose

Change in mean glucose assessed by a continuous glucose monitor (CGM) expressed as mg/dL. Change in mean glucose will be calculated as mean glucose assessed from 7 days of CGM wear at 12 weeks minus mean glucose assessed from 7 days of CGM wear at baseline.

Time frame: 12-weeks

Change in mean time in range

Change in mean time in range (glucose 70-140 mg/dL) assessed by a continuous glucose monitor (CGM) expressed as minutes per day. Change in mean time in range will be calculated as mean time in range assessed from 7 days of CGM wear at 12 weeks minus mean time in range assessed from 7 days of CGM wear at baseline.

Time frame: 12-weeks

Change in glycemic variability

Change in mean glycemic variability assessed by a continuous glucose monitor (CGM) expressed as the coefficient of variability. Change in mean glycemic variability will be calculated as mean glycemic variability assessed from 7 days of CGM wear at 12 weeks minus mean glycemic variability assessed from 7 days of CGM wear at baseline.

Time frame: 12-weeks

Change in fasting insulin

Central Contacts

Kristina Petersen, PhD

CONTACT

814-865-7206 kup63@psu.edu

Stacey Meily

CONTACT

814-863-8622 sas117@psu.edu

Data from ClinicalTrials.gov

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