NCT07235358

Brief Summary

The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started May 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Sep 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

November 14, 2025

Last Update Submit

April 14, 2026

Conditions

Prediabetes

Keywords

dietnutritionnutssnackingprediabetescardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    HbA1c will be assessed at baseline and 16-weeks and expressed as percentage . The change in HbA1c will be calculated by subtracting the baseline value from the 16 week value and expressed as percentage point change.

    16 weeks

Secondary Outcomes (21)

  • Change in fasting glucose

    16 weeks

  • Change in mean glucose

    16 weeks

  • Change in mean time in range

    16 weeks

  • Change in glycemic variability

    16 weeks

  • Change in fasting insulin

    16 weeks

  • +16 more secondary outcomes

Study Arms (2)

Pecan snacking group

EXPERIMENTAL

Participants will be provided with 1.5 oz/day of pecans and asked to eat these instead of typically consumed snacks higher in saturated fat and added sugars.

Behavioral: Pecan snacking

Usual diet

ACTIVE COMPARATOR

Participants will be asked to continue consuming their usual diet. To match attention and resources, participants will be provided with a grocery voucher in approximately equivalent value to the pecans.

Other: Usual diet

Interventions

Pecan snackingBEHAVIORAL

Replacement of typically consumed snacks with 1.5 oz/day of pecans

Pecan snacking group
Usual dietOTHER

Continue with usual diet

Usual diet

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25-65 years
  • Prediabetes assessed by an HbA1c of 5.7-6.4% at screening
  • BMI 25-40 kg/m2 at screening
  • Low habitual nut consumption (\<3.5 oz-eq/week) assessed at the telephone screening
  • Regularly eats snacks higher in saturated fat and/or added sugars assessed at the telephone screening

You may not qualify if:

  • LDL-C ≥190 mg/dL at screening
  • Hemoglobin \<13.2 g/dL at screening
  • Fasting triglycerides \>350 mg/dL at screening
  • ≥10% change in body weight within the 6 months prior to enrollment
  • Blood pressure \>140/90 mmHg at screening
  • Type 1 or type 2 diabetes
  • Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs
  • Intake of supplements or over-the-counter medications that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the study period.
  • History of liver, kidney, or autoimmune disease
  • Prior cardiovascular event (e.g., stroke, heart attack)
  • Current pregnancy or intention of pregnancy within the next 12 months
  • Lactation within the prior 6 months
  • Pecan allergy/intolerance/sensitivity/dislike
  • Unwilling/unable to eat 1.5 oz of pecans every day as a snack during the duration of the study
  • Antibiotic use within the prior 4 weeks
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic StateCardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kristina Petersen, PhD

CONTACT

814-865-7206kup63@psu.edu

Stacey Meily

CONTACT

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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

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.