Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes

ConditionPrediabetes

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-65

SponsorPenn State University

About this trial

The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-65 years

BMI 25 to 40 kg/m2

HbA1c 5.7-6.4%

Low habitual intake of peanut butter (<0.5 Tablespoons/day on average)

Disqualifiers

Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening

Fasting triglycerides >350 mg/dL at screening

LDL-cholesterol ≥190 mg/dL assessed by the Martin-Hopkins equation at screening

≥10% change in body weight within the 6 months prior to enrollment

Trial design

Design model

Crossover

Treatments tested in this trial

Peanut butter
Other intervention
Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Usual diet
Other intervention
Continue intake of usual diet.

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: Peanut Butter-Usual DietExperimental treatment 2 interventions

Group B: Usual Diet-Peanut ButterActive comparator 2 interventions

Trial outcomes

Primary outcomes

Change in HbA1c

HbA1c will be assessed at the beginning and end of each 12-week period and expressed as percentage. The change in HbA1c will be calculated as the post-condition value minus the pre-condition 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 post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.

Time frame

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 post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.

Time frame

12 weeks

Mean glucose

Mean glucose assessed by a continuous glucose monitor (CGM) expressed as mg/dL. The between-condition difference in mean glucose will be evaluated by comparing the mean glucose calculated from 7 days of CGM wear at the end of each study period.

Time frame

12 weeks

Mean glucose time in range

Mean glucose time in range (70-140 mg/dL) assessed by a continuous glucose monitor (CGM) expressed as minutes per day. The between-condition difference in mean glucose time in range will be evaluated by comparing the mean glucose time in range from 7 days of CGM wear at the end of each study period.

Time frame

12 weeks

Other outcomes

Difference in microbiota composition

Microbiota composition assessed by 16S rRNA sequencing. The between-condition difference in microbiota composition will be evaluated by alpha and beta diversity and taxa profile at the end of each study period.

Time frame

12 weeks

Sponsors and contacts

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

Penn State University

Lead sponsor

Source ClinicalTrials.gov

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