Health TrialsbyHealthPanel

Mediterranean Diet and Blood Sugar Study

ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mediterranean-style diet with potatoes

    Other intervention

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

  • Traditional-style Mediterranean diet

    Other intervention

    Traditional-style Mediterranean diet higher in grains

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Mediterranean-style diet with potato (MED-P)Experimental treatment 1 intervention
Group B: Traditional-style Mediterranean dietary pattern (MED)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

Alliance for Potato Research and Education

Collaborator

Source ClinicalTrials.gov
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