Menu
Not yet recruiting NCT07714096

Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes

No phase Interventional Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peanut butter, Usual diet.
Who it may be relevant to
Registry conditions: Prediabetes. Basic parameters: 40 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Peanut Butter Glycemic Control, Cognition and Cardiovascular Health

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Change in HbA1c [Time frame: 12 weeks]
Secondary outcome measures (12)
  • Change in fasting glucose [Time frame: 12 weeks]
  • Change in fasting insulin [Time frame: 12 weeks]
  • Mean glucose [Time frame: 12 weeks]
  • Mean glucose time in range [Time frame: 12 weeks]
  • Glycemic variability [Time frame: 12 weeks]
  • Change in homeostatic model of insulin resistance (HOMA-IR) [Time frame: 12 weeks]
  • Difference in ambulatory processing speed [Time frame: 12 weeks]
  • Difference in ambulatory working memory [Time frame: 12 weeks]
  • Difference in ambulatory attention [Time frame: 12 weeks]
  • Change in body weight [Time frame: 12 weeks]
  • Difference in hunger [Time frame: 12 weeks]
  • Difference in satiety [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • The Pennsylvania State University — University Park

Identifiers

NCT: NCT07714096 · PB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗