NCT07714096

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Jan 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2027

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 14, 2026

Last Update Submit

July 15, 2026

Conditions

Prediabetes

Keywords

dietnutritionpeanut buttercognitionheart diseaseglycemic controlcardiovascular diseasediabetes

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (21)

  • Change in fasting glucose

    12 weeks

  • Change in fasting insulin

    12 weeks

  • Mean glucose

    12 weeks

  • Mean glucose time in range

    12 weeks

  • Glycemic variability

    12 weeks

  • +16 more secondary outcomes

Other Outcomes (1)

  • Difference in microbiota composition

    12 weeks

Study Arms (2)

Peanut Butter-Usual Diet

EXPERIMENTAL

In the first period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day). In the second period, participants will be instructed to continue their usual intake.

Other: Peanut butterOther: Usual diet

Usual Diet-Peanut Butter

ACTIVE COMPARATOR

In the first period, participants will be instructed to continue their usual intake. In the second period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day).

Other: Peanut butterOther: Usual diet

Interventions

Peanut butterOTHER

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

Peanut Butter-Usual DietUsual Diet-Peanut Butter
Usual dietOTHER

Continue intake of usual diet.

Peanut Butter-Usual DietUsual Diet-Peanut Butter

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Prediabetic StateHeart DiseasesCardiovascular DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kristina Petersen, PhD

CONTACT

+1 814 865 7206kup63@psu.edu

Stacey Meily

CONTACT

+1 814 863 8622sas117@psu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 20, 2026

Study Start (Estimated)

January 18, 2027

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The SAP and protocol will be posted on clinicaltrials.gov prior to enrollment commencing.

Locations

US(1)