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| Name | Class |
|---|---|
| Alliance for Potato Research & Education | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean-style diet with potato (MED-P) | Experimental | Mediterranean-style diet that includes 1 medium potato/day/2000 kcal replacing some grains |
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| Traditional-style Mediterranean dietary pattern (MED) | Active Comparator | A traditional-style Mediterranean diet that does not contain potatoes (potatoes are not a defining feature of this diet) and is higher in grains. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean-style diet with potatoes | Other | The diet will contain 1 medium potato/day/2000 kcal |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-weeks |
| Change in mean glucose |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Petersen, PhD | Contact | 814-865-7206 | kup63@psu.edu | |
| Stacey Meily | Contact | 814-863-8622 | sas117@psu.edu |
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The SAP and protocol will be posted on clinicaltrials.gov prior to enrollment commencing.
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Traditional-style Mediterranean diet | Other | Traditional-style Mediterranean diet higher in grains |
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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. |
| 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. | 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. | 12-weeks |
| Change in fasting insulin | Change in fasting serum insulin expressed as micro IU/mL. Change in insulin 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). | 12-weeks |
| Change in homeostatic model of insulin resistance (HOMA-IR) | Homeostatic model of insulin resistance (HOMA-IR) will be calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5. Change in HOMA-IR 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). | 12-weeks |
| Change in LDL-Cholesterol | Assessed from fasting blood draw expressed in mg/dL. Change in LDL-cholesterol 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). | 12-weeks |
| Change in apolipoprotein B | Assessed from fasting blood draw expressed in mg/dL. Change in apolipoprotein B will be calculated by subtracting the baseline value from the 12 week value. | 12-weeks |
| Change in non-HDL cholesterol | Assessed from fasting blood draw expressed in mg/dL. Change in non-HDL cholesterol 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). | 12-weeks |
| Change in Total Cholesterol | Assessed from fasting blood draw expressed in mg/dL. Change in total cholesterol 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). | 12-weeks |
| Change in HDL-Cholesterol | Assessed from fasting blood draw expressed in mg/dL. Change in HDL-cholesterol 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). | 12-weeks |
| Change in Triglycerides | Assessed from fasting blood draw expressed in mg/dL. Change in triglycerides 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). | 12-weeks |
| Change in C-reactive protein | Assessed from fasting blood draw expressed in mg/L. Change in C-reactive protein 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). | 12-weeks |
| Change in Central Systolic and Diastolic Blood Pressure | Central blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) at baseline & 12 weeks. Change will be calculated by subtracting the baseline value from the end point value. | 12-weeks |
| Change in Peripheral Systolic and Diastolic Blood Pressure | Peripheral blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) at baseline & 12 weeks. Change will be calculated by subtracting the baseline value from the end point value. | 12-weeks |
| Change in Carotid-Femoral Pulse Wave Velocity | Measured assessed using a SphymoCor Xcel (Atcor Medical) at baseline & 12 weeks. Change will be calculated by subtracting the baseline value from the end point value. | 12-weeks |
| Change in particle size and number of LDL, HDL, triglyceride rich lipoproteins | Measured via Nuclear Magnetic Resonance | 12-weeks |
| Diet Satisfaction | Participants will complete a survey that we have previously developed to assess diet satisfaction at 12 weeks. | 12-weeks |
| D004700 | Endocrine System Diseases |