Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes

N/ANot Yet RecruitingNCT07714096

Penn State University56 enrolled

Overview

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.

This is a 2-period, randomized, crossover study. In random sequence order participants will undergo each of the following conditions for 12 weeks with a ≥ 8-week washout between the two periods: 1) provision of 43 g/day (1.5 oz/day) of peanut butter with instructions to consume it as part of breakfast (or the first meal of the day); 2) instructions to continue usual intake with matched study contact and resource provision. Testing will be conducted at the beginning and end of each period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Prediabetes

Interventions

Peanut butterOTHER

Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)

Usual dietOTHER

Continue intake of usual diet.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) * Have a smartphone device or be willing to use one provided by the study Exclusion Criteria: * 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 * Blood pressure \>140/90 mmHg at screening * Diagnosed type 1 or type 2 diabetes * Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or body weight altering drugs * Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, and microbiome) and are unwilling to cease during the study period. * Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study * Self-reported history of diagnosed liver, kidney, or autoimmune disease * Self-reported history of a prior cardiovascular event (e.g., stroke, heart attack) * Self-reported history of diagnosed neurological disease (e.g. Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis) * Current pregnancy or intention of pregnancy within the next 12 months * Lactation within the prior 6 months * Peanut allergy/intolerance/sensitivity/dislike * Antibiotic use within the prior four weeks * Oral steroid use within the prior four weeks * 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 * Does not speak and/or understand English * Unwilling to refrain from donating blood and/or plasma during the study * Weight \<110 lb * Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study * For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months * Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits

Locations (1)

The Pennsylvania State University

University Park, Pennsylvania, United States

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

Glycemic variability

Glycemic variability assessed by a continuous glucose monitor (CGM) expressed as the coefficient of variability. The between-condition difference in glycemic variability will be evaluated by comparing the glycemic variability calculated from 7 days of CGM wear at the end of each study period.

Central Contacts

Kristina Petersen, PhD

CONTACT

+1 814 865 7206 kup63@psu.edu

Stacey Meily

CONTACT

+1 814 863 8622 sas117@psu.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 12 weeks

Change in homeostatic model of insulin resistance (HOMA-IR)

HOMA-IR will be calculated as (fasting insulin μIU/mL × fasting glucose mg/dL) / 405. Change in HOMA-IR 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

Difference in ambulatory processing speed

Ambulatory processing speed assessed by ecological momentary assessment (EMA) administered Symbol Search, expressed as median response time correct. The between-condition difference in ambulatory processing speed will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.

Time frame: 12 weeks

Difference in ambulatory working memory

Ambulatory working memory assessed by ecological momentary assessment (EMA) administered Grid Memory, expressed as number of correct dots. The between-condition difference in ambulatory working memory will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.

Time frame: 12 weeks

Difference in ambulatory attention

Ambulatory attention assessed by ecological momentary assessment (EMA) administered Multiple Object Tracking expressed as number of correct dots. The between-condition difference in ambulatory attention will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.

Time frame: 12 weeks

Change in body weight

Change in body weight expressed as kg. Change in body weight 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

Difference in hunger

Hunger assessed by ecological momentary assessment (EMA) administered visual analog scale (scored 0-100). The between-condition difference in hunger will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.

Time frame: 12 weeks

Difference in satiety

Satiety assessed by ecological momentary assessment (EMA) administered visual analog scale (scored 0-100). The between-condition difference in satiety will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.

Time frame: 12 weeks

Change in total cholesterol

Change in fasting serum total cholesterol expressed as mg/dL. Change in total cholesterol 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 LDL-cholesterol

Change in fasting serum LDL-cholesterol calculated with the Martin-Hopkins equation expressed as mg/dL. Change in LDL-cholesterol 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 triglycerides

Change in fasting serum triglycerides expressed as mg/dL. Change in triglycerides 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 HDL-cholesterol

Change in fasting serum HDL-cholesterol expressed as mg/dL. Change in HDL-cholesterol 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 non-HDL cholesterol

Change in fasting serum non-HDL cholesterol expressed as mg/dL. Change in non-HDL cholesterol 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 central systolic and diastolic blood pressure

Change in central blood pressure measured using a SphymoCor Xcel (Atcor Medical) expressed as mmHg. Change in systolic and diastolic blood pressure will be calculated as the post-condition value minus the pre-condition value and expressed as mmHg.

Time frame: 12 weeks

Change in peripheral systolic and diastolic blood pressure

Change in peripheral blood pressure measured using a SphymoCor Xcel (Atcor Medical) expressed as mmHg. Change in systolic and diastolic blood pressure will be calculated as the post-condition value minus the pre-condition value and expressed as mmHg.

Time frame: 12 weeks

Change in carotid-femoral pulse wave velocity

Change in carotid-femoral pulse wave velocity (PWV) measured using a SphymoCor Xcel (Atcor Medical) expressed as m/s. Change in PWV will be calculated as the post-condition value minus the pre-condition value and expressed as m/s.

Time frame: 12 weeks

Change in diet quality

Assessed from a 24-hour recall completed prior to the beginning of each study period and at the end of each study period. Diet quality will be calculated according to the Healthy Eating Index-2020 (HEI). Change in HEI will be calculated at the post-condition value minus the pre-condition value

Time frame: 12 weeks