PrediabetesNCT07235358
Cardiometabolic Effects of Pecan Snacking in Prediabetes
A study testing Pecan snacking and Usual diet in people with Prediabetes, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Pecan snacking and Usual diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Pennsylvania State University
University Park, Pennsylvania, 16802
Kristina Petersen, PhD, 814-865-7206, kup63@psu.edu
About this study
Official title: Glycemic Effects of Substituting Pecans for Snacks Higher in Saturated Fat and Added Sugars in Individuals With Prediabetes
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.
Read the detailed description
This is a 16-week randomized controlled trial. Participants will be randomized to either: 1) replace current snacks higher in saturated fat and added sugars with 1.5 oz/day of pecans; 2) continue their habitual diet. At the beginning and the end of the 16-week study period, testing will be conducted.
- Conditions
- Prediabetes
- Being tested
- Pecan snacking, Usual diet
- Keywords
- diet, nutrition, nuts, snacking, prediabetes, cardiovascular disease
- Medical subject headings
- Prediabetic State, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan snackingBehavioural
Replacement of typically consumed snacks with 1.5 oz/day of pecans
Usual dietOther
Continue with usual diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (21)
Change in fasting glucose
Change in fasting plasma glucose expressed as mg/dL. Change in glucose will be calculated as the mean of the 16 week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in mean glucose
Change in mean glucose assessed by a continuous glucose monitor (CGM) expressed as mg/dL. Change in mean glucose will be calculated as mean glucose assessed from 7 days of CGM wear at 16 weeks minus mean glucose assessed from 7 days of CGM wear at baseline.
Measured: 16 weeks
Change in mean time in range
Change in mean time in range (glucose 70-140 mg/dL) assessed by a continuous glucose monitor (CGM) expressed as minutes per day. Change in mean time in range will be calculated as mean time in range assessed from 7 days of CGM wear at 16 weeks minus mean time in range assessed from 7 days of CGM wear at baseline.
Measured: 16 weeks
Change in glycemic variability
Change in mean glycemic variability assessed by a continuous glucose monitor (CGM) expressed as the coefficient of variability. Change in mean glycemic variability will be calculated as mean glycemic variability assessed from 7 days of CGM wear at 16 weeks minus mean glycemic variability assessed from 7 days of CGM wear at baseline.
Measured: 16 weeks
Change in fasting insulin
Change in fasting serum insulin expressed as micro IU/mL. Change in insulin will be calculated as the mean of the 16 week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in homeostatic model of insulin resistance (HOMA-IR)
Homeostatic model of insulin resistance (HOMA-IR) will be calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5. Change in HOMA-IR will be calculated as the mean of the 16 week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in the lipoprotein insulin resistance index
The lipoprotein insulin resistance index will be calculated from Nuclear Magnetic Resonance assessed lipoprotein concentrations according to a previously described method: Metab, Syndr. Relat. Disord. 12 (8) (2014) 422-429. Change will be calculated by subtracting the baseline value from the 16 week value.
Measured: 16 weeks
Change in LDL-Cholesterol
Assessed from fasting blood draw expressed in mg/dL. Change in LDL-cholesterol will be calculated as the mean of the 16-week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in apolipoprotein B
Assessed from fasting blood draw expressed in mg/dL. Change in apolipoprotein B will be calculated by subtracting the baseline value from the 16 week value.
Measured: 16 weeks
Change in non-HDL cholesterol
Assessed from fasting blood draw expressed in mg/dL. Change in non-HDL cholesterol will be calculated as the mean of the 16-week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in Total Cholesterol
Assessed from fasting blood draw expressed in mg/dL. Change in total cholesterol will be calculated as the mean of the 16-week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in HDL-Cholesterol
Assessed from fasting blood draw expressed in mg/dL. Change in HDL-cholesterol will be calculated as the mean of the 16-week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in Triglycerides
Assessed from fasting blood draw expressed in mg/dL. Change in triglycerides will be calculated as the mean of the 16-week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in C-reactive protein
Assessed from fasting blood draw expressed in mg/L. Change in C-reactive protein will be calculated as the mean of the 16-week measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 16 weeks
Change in Central Systolic and Diastolic Blood Pressure
Central blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) at baseline \& 16 weeks. Change will be calculated by subtracting the baseline value from the end point value.
Measured: 16 weeks
Change in Peripheral Systolic and Diastolic Blood Pressure
Peripheral blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) at baseline \& 16 weeks. Change will be calculated by subtracting the baseline value from the end point value.
Measured: 16 weeks
Change in Carotid-Femoral Pulse Wave Velocity
Measured assessed using a SphymoCor Xcel (Atcor Medical) at baseline \& 16 weeks. Change will be calculated by subtracting the baseline value from the end point value.
Measured: 16 weeks
Change in particle size and number of LDL, HDL, triglyceride rich lipoproteins
Measured via Nuclear Magnetic Resonance at baseline and 16 weeks. The change will be calculated by subtracting the baseline value from the 16 week value.
Measured: 16 weeks
Change in Saturated fat intake
Assessed from 24-hour recalls completed prior to baseline and at 16 weeks. Change in saturated fat will be calculated as saturated fat intake at 16 weeks minus baseline saturated fat intake.
Measured: 16 weeks
Change in added sugar intake
Assessed from 24-hour recalls completed prior to baseline and at 16 weeks. Change in added sugar intake will be calculated as added sugar intake at 16 weeks minus baseline added sugar intake.
Measured: 16 weeks
Change in diet quality
Assessed from 24-hour recalls completed prior to baseline and at 16 weeks. Diet quality will be calculated according to the Healthy Eating Index-2020 (HEI). Change in HEI will be calculated as HEI at 16 weeks minus baseline HEI.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start22 May 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pecan Promotion Board
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235358
- Sponsor's protocol ID
- PEC
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Effects of Substituting Pecans for Snacks Higher in Saturated Fat and Added Sugars in Individuals With Prediabetes
- ClinicalTrials.gov ID
- NCT07235358
- Acronym / sponsor ID
- PEC
- Conditions
- Prediabetes
- Keywords
- diet, nutrition, nuts, snacking, prediabetes, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- American Pecan Promotion Board
- Study start
- 22 May 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 16-week randomized controlled trial. Participants will be randomized to either: 1) replace current snacks higher in saturated fat and added sugars with 1.5 oz/day of pecans; 2) continue their habitual diet. At the beginning and the end of the 16-week study period, testing will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pecan snacking group | Experimental | Behavioral: Pecan snackingParticipants 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. |
| Usual diet | Active comparator | Other: Usual dietParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pecan snackingReplacement of typically consumed snacks with 1.5 oz/day of pecans | Behavioural | Pecan snacking group |
| Usual dietContinue with usual diet | Other | Usual diet |
Primary outcome
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.
21 secondary outcomes
Change in fasting glucose
Time frame: 16 weeks
Change in mean glucose
Time frame: 16 weeks
Change in mean time in range
Time frame: 16 weeks
Change in glycemic variability
Time frame: 16 weeks
Change in fasting insulin
Time frame: 16 weeks
Change in homeostatic model of insulin resistance (HOMA-IR)
Time frame: 16 weeks
Change in the lipoprotein insulin resistance index
Time frame: 16 weeks
Change in LDL-Cholesterol
Time frame: 16 weeks
Change in apolipoprotein B
Time frame: 16 weeks
Change in non-HDL cholesterol
Time frame: 16 weeks
Change in Total Cholesterol
Time frame: 16 weeks
Change in HDL-Cholesterol
Time frame: 16 weeks
Change in Triglycerides
Time frame: 16 weeks
Change in C-reactive protein
Time frame: 16 weeks
Change in Central Systolic and Diastolic Blood Pressure
Time frame: 16 weeks
Change in Peripheral Systolic and Diastolic Blood Pressure
Time frame: 16 weeks
Change in Carotid-Femoral Pulse Wave Velocity
Time frame: 16 weeks
Change in particle size and number of LDL, HDL, triglyceride rich lipoproteins
Time frame: 16 weeks
Change in Saturated fat intake
Time frame: 16 weeks
Change in added sugar intake
Time frame: 16 weeks
Change in diet quality
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan snacking and Usual diet in people with Prediabetes, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Petersen, PhD (814-865-7206, kup63@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.