NCT07235358 · Penn State University
Cardiometabolic Effects of Pecan Snacking in Prediabetes
What this study is about
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 randomly assigned into one of two groups. Group 1 will consume 1.
View original scientific description
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.
Interventions
BEHAVIORAL
Pecan snacking
Replacement of typically consumed snacks with 1.5 oz/day of pecans
OTHER
Usual diet
Continue with usual diet
Primary outcome measures
Change in HbA1c
Time frame: 16 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- University Park, Pennsylvania
Collaborators
American Pecan Promotion Board
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations