NCT06867198

Brief Summary

The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress47%
Mar 2025Sep 2027

First Submitted

Initial submission to the registry

March 4, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

March 4, 2025

Last Update Submit

March 23, 2026

Conditions

PrediabetesCognitionMicrovascular FunctionGut MicrobiotaEndothelial Function (Reactive Hyperemia)Arterial Stiffness, Blood PressureAdultPrediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Keywords

prediabetespeanutsfunctional foodsnutsmetabolic healthinsulin resistancetype II diabetesmicrovascular functiondietary interventioncognitive functionvascular functionneuroimagingendothelial functioncardiovascular healthgut microbiota

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose

    Measurement of fasting blood glucose

    Baseline, 3 months, and 6 months

  • Glycosylated hemoglobin

    Measurement of fasting glycosylated hemoglobin

    Baseline, 3 months, and 6 months

Secondary Outcomes (15)

  • Ambulatory Blood Pressure

    Baseline, 3 months, and 6 months

  • Fasting Insulin

    Baseline, 3 months, and 6 months

  • Homeostasis model assessment-insulin resistance (HOMA-R)

    Baseline, 3 months, and 6 months

  • Blood Lipid Profile

    Baseline, 3 months, and 6 months

  • Gut Microbiota Composition

    Baseline, 3 months, and 6 months

  • +10 more secondary outcomes

Other Outcomes (8)

  • Reactive Hyperemia Index

    Baseline, 3 months, and 6 months

  • Pulse Wave Velocity

    Baseline, 3 months, and 6 months

  • Percent Maximal Microvascular Blood Flow

    Baseline, 3 months, and 6 months

  • +5 more other outcomes

Study Arms (2)

Peanut

EXPERIMENTAL

43 g of peanut butter (1snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months

Dietary Supplement: Peanuts

Control

NO INTERVENTION

No intervention

Interventions

PeanutsDIETARY_SUPPLEMENT

43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months.

Peanut

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men and women
  • years of age
  • BMI: 24.5 - 35.5 kg/m\^2
  • Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
  • Ability to give consent

You may not qualify if:

  • Allergies to peanuts and peanut products
  • Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
  • Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury
  • Smoking
  • Consumes greater than 2 alcoholic beverages per day
  • Consumes antioxidant, probiotic, and prebiotic supplements
  • Pregnant or Lactating
  • Actively participating in a weight loss program
  • Certain neurological disorders (e.g., uncontrolled seizure disorders)
  • Braces on their teeth, a cardiac pacemaker; hearing aid; other metal in the body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic StateInsulin ResistanceGlucose IntoleranceHyperemiaDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismHyperglycemiaVascular DiseasesCardiovascular Diseases

Study Officials

  • Rafaela G Feresin, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafaela G Feresin, PhD

CONTACT

404-413-1233peanuts@gsu.edu

Study Design

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

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 27, 2026

Record last verified: 2025-03

Locations

US(1)