Recruiting

Pecans

Sponsor:

Penn State University

Code:

NCT07235358

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Pecan snacking

Usual diet

Study Details

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.

Conditions

Prediabetes

Study ID

NCT07235358

Start date

May 22, 2026

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Oral steroid use within the prior 4 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
  • Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study.
  • 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
  • Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
  • Does not speak and/or understand English
  • Unwilling to refrain from donating blood or plasma during the study
  • Weight <110 lb
  • If a potential participant takes thyroid medicine, abnormal thyroid stimulated hormone (TSH) concentration (TSH outside of normal range), or change in dose of thyroid medication within the last 6 months

Study Design

Enrollment

147 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Pecan snacking group

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.

active comparator: Usual diet

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.

Interventions

Pecan snacking

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

Usual diet

Continue with usual diet

Primary outcome measure

  • Change in HbA1c [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Kristina Petersen, PhD

814-865-7206kup63@psu.edu

Stacey Meily

814-863-8622sas117@psu.edu

Locations

The Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Kristina Petersen, PhD

814-865-7206kup63@psu.edu

More Information

Sponsor

Penn State University

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • diet
  • nutrition
  • nuts
  • snacking
  • prediabetes
  • cardiovascular disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-05-27.