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Cardiometabolic Effects of Pecan Snacking in Prediabetes

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

About this trial

The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 25-65 years

Prediabetes assessed by an HbA1c of 5.7-6.4% at screening

BMI 25-40 kg/m2 at screening

Low habitual nut consumption (<3.5 oz-eq/week) assessed at the telephone screening

Disqualifiers

LDL-C ≥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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pecan snacking

    Behavioral

    Replacement of typically consumed snacks with 1.5 oz/day of pecans

  • Usual diet

    Other intervention

    Continue with usual diet

Treatment groups

147 Participants
are divided into 2 treatment groups
Group A: Pecan snacking groupExperimental treatment 1 intervention
Group B: Usual dietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c

HbA1c will be assessed at baseline and 16-weeks and expressed as percentage . The change in HbA1c will be calculated by subtracting the baseline value from the 16 week value and expressed as percentage point change.

Time frame
16 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 16 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
16 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 16 weeks minus mean glucose assessed from 7 days of CGM wear at baseline.

Time frame
16 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 16 weeks minus mean time in range assessed from 7 days of CGM wear at baseline.

Time frame
16 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 16 weeks minus mean glycemic variability assessed from 7 days of CGM wear at baseline.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

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

Penn State University

Lead sponsor

American Pecan Promotion Board

Collaborator

Source ClinicalTrials.gov
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