Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes
Starting soon · Not applicable
Conditions studied: Prediabetes
In brief
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.
Key facts
- Study ID
- NCT07714096
- Run by
- Penn State University
- People needed
- 56
- Starts
- 2027-01-18
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2026-07-20
Who can join
Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Pennsylvania State University — University Park, Pennsylvania, United States
Full record on ClinicalTrials.gov
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