PrediabetesNCT07714096
Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes
A study testing Peanut butter 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 look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Peanut butter and Usual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2027to 31 Oct 2028
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-65 years
- BMI 25 to 40 kg/m2
- HbA1c 5.7-6.4%
- Low habitual intake of peanut butter (<0.5 Tablespoons/day on average)
- Have a smartphone device or be willing to use one provided by the study
Who cannot join
- Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening
- Fasting triglycerides >350 mg/dL at screening
- LDL-cholesterol ≥190 mg/dL assessed by the Martin-Hopkins equation at screening
- ≥10% change in body weight within the 6 months prior to enrollment
- Blood pressure >140/90 mmHg at screening
- Diagnosed type 1 or type 2 diabetes
Show all 29Show fewer
- Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or body weight altering drugs
- Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, and microbiome) and are unwilling to cease during the study period.
- Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study
- Self-reported history of diagnosed liver, kidney, or autoimmune disease
- Self-reported history of a prior cardiovascular event (e.g., stroke, heart attack)
- Self-reported history of diagnosed neurological disease (e.g. Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis)
- Current pregnancy or intention of pregnancy within the next 12 months
- Lactation within the prior 6 months
- Peanut allergy/intolerance/sensitivity/dislike
- Antibiotic use within the prior four weeks
- Oral steroid use within the prior four 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
- 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
- Does not speak and/or understand English
- Unwilling to refrain from donating blood and/or plasma during the study
- Weight <110 lb
- Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study
- For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months
- Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
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
The Pennsylvania State University
University Park, Pennsylvania, 16802
Kristina Petersen, PhD, +1 814-865 7206, kup63@psu.edu
About this study
Official title: Peanut Butter Glycemic Control, Cognition and Cardiovascular Health
The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.
Read the detailed description
This is a 2-period, randomized, crossover study. In random sequence order participants will undergo each of the following conditions for 12 weeks with a ≥ 8-week washout between the two periods: 1) provision of 43 g/day (1.5 oz/day) of peanut butter with instructions to consume it as part of breakfast (or the first meal of the day); 2) instructions to continue usual intake with matched study contact and resource provision. Testing will be conducted at the beginning and end of each period.
- Conditions
- Prediabetes
- Being tested
- Peanut butter, Usual diet
- Keywords
- diet, nutrition, peanut butter, cognition, heart disease, glycemic control, cardiovascular disease, diabetes
- Medical subject headings
- Prediabetic State, Heart Diseases, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut butterOther
Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Usual dietOther
Continue intake of usual diet.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Butter-Usual Diet | Experimental | In the first period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day). In the second period, participants will be instructed to continue their usual intake. Receives: Other: Peanut butter; Other: Usual diet |
| Usual Diet-Peanut Butter | Active comparator | In the first period, participants will be instructed to continue their usual intake. In the second period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day). Receives: Other: Peanut butter; 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 the beginning and end of each 12-week period and expressed as percentage. The change in HbA1c will be calculated as the post-condition value minus the pre-condition value and expressed as percentage point change.
Measured: 12 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 post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 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 post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Mean glucose
Mean glucose assessed by a continuous glucose monitor (CGM) expressed as mg/dL. The between-condition difference in mean glucose will be evaluated by comparing the mean glucose calculated from 7 days of CGM wear at the end of each study period.
Measured: 12 weeks
Mean glucose time in range
Mean glucose time in range (70-140 mg/dL) assessed by a continuous glucose monitor (CGM) expressed as minutes per day. The between-condition difference in mean glucose time in range will be evaluated by comparing the mean glucose time in range from 7 days of CGM wear at the end of each study period.
Measured: 12 weeks
Glycemic variability
Glycemic variability assessed by a continuous glucose monitor (CGM) expressed as the coefficient of variability. The between-condition difference in glycemic variability will be evaluated by comparing the glycemic variability calculated from 7 days of CGM wear at the end of each study period.
Measured: 12 weeks
Change in homeostatic model of insulin resistance (HOMA-IR)
HOMA-IR will be calculated as (fasting insulin μIU/mL × fasting glucose mg/dL) / 405. Change in HOMA-IR will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Difference in ambulatory processing speed
Ambulatory processing speed assessed by ecological momentary assessment (EMA) administered Symbol Search, expressed as median response time correct. The between-condition difference in ambulatory processing speed will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
Measured: 12 weeks
Difference in ambulatory working memory
Ambulatory working memory assessed by ecological momentary assessment (EMA) administered Grid Memory, expressed as number of correct dots. The between-condition difference in ambulatory working memory will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
Measured: 12 weeks
Difference in ambulatory attention
Ambulatory attention assessed by ecological momentary assessment (EMA) administered Multiple Object Tracking expressed as number of correct dots. The between-condition difference in ambulatory attention will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
Measured: 12 weeks
Change in body weight
Change in body weight expressed as kg. Change in body weight will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Difference in hunger
Hunger assessed by ecological momentary assessment (EMA) administered visual analog scale (scored 0-100). The between-condition difference in hunger will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
Measured: 12 weeks
Difference in satiety
Satiety assessed by ecological momentary assessment (EMA) administered visual analog scale (scored 0-100). The between-condition difference in satiety will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
Measured: 12 weeks
Change in total cholesterol
Change in fasting serum total cholesterol expressed as mg/dL. Change in total cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Change in LDL-cholesterol
Change in fasting serum LDL-cholesterol calculated with the Martin-Hopkins equation expressed as mg/dL. Change in LDL-cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Change in triglycerides
Change in fasting serum triglycerides expressed as mg/dL. Change in triglycerides will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Change in HDL-cholesterol
Change in fasting serum HDL-cholesterol expressed as mg/dL. Change in HDL-cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Change in non-HDL cholesterol
Change in fasting serum non-HDL cholesterol expressed as mg/dL. Change in non-HDL cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
Measured: 12 weeks
Change in central systolic and diastolic blood pressure
Change in central blood pressure measured using a SphymoCor Xcel (Atcor Medical) expressed as mmHg. Change in systolic and diastolic blood pressure will be calculated as the post-condition value minus the pre-condition value and expressed as mmHg.
Measured: 12 weeks
Change in peripheral systolic and diastolic blood pressure
Change in peripheral blood pressure measured using a SphymoCor Xcel (Atcor Medical) expressed as mmHg. Change in systolic and diastolic blood pressure will be calculated as the post-condition value minus the pre-condition value and expressed as mmHg.
Measured: 12 weeks
Change in carotid-femoral pulse wave velocity
Change in carotid-femoral pulse wave velocity (PWV) measured using a SphymoCor Xcel (Atcor Medical) expressed as m/s. Change in PWV will be calculated as the post-condition value minus the pre-condition value and expressed as m/s.
Measured: 12 weeks
Change in diet quality
Assessed from a 24-hour recall completed prior to the beginning of each study period and at the end of each study period. Diet quality will be calculated according to the Healthy Eating Index-2020 (HEI). Change in HEI will be calculated at the post-condition value minus the pre-condition value
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start18 Jan 2027 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714096
- Sponsor's protocol ID
- PB
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Butter Glycemic Control, Cognition and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07714096
- Acronym / sponsor ID
- PB
- Conditions
- Prediabetes
- Keywords
- diet, nutrition, peanut butter, cognition, heart disease, glycemic control, cardiovascular disease, diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 18 Jan 2027 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 20 Jul 2026 (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 look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.
Detailed description
This is a 2-period, randomized, crossover study. In random sequence order participants will undergo each of the following conditions for 12 weeks with a ≥ 8-week washout between the two periods: 1) provision of 43 g/day (1.5 oz/day) of peanut butter with instructions to consume it as part of breakfast (or the first meal of the day); 2) instructions to continue usual intake with matched study contact and resource provision. Testing will be conducted at the beginning and end of each period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Butter-Usual Diet | Experimental | Other: Peanut butter, Other: Usual dietIn the first period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day). In the second period, participants will be instructed to continue their usual intake. |
| Usual Diet-Peanut Butter | Active comparator | Other: Peanut butter, Other: Usual dietIn the first period, participants will be instructed to continue their usual intake. In the second period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-65 years
- BMI 25 to 40 kg/m2
- HbA1c 5.7-6.4%
- Low habitual intake of peanut butter (<0.5 Tablespoons/day on average)
- Have a smartphone device or be willing to use one provided by the study
Key exclusion criteria (29 listed)
- Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening
- Fasting triglycerides >350 mg/dL at screening
- LDL-cholesterol ≥190 mg/dL assessed by the Martin-Hopkins equation 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 |
|---|---|---|
| Peanut butterIntake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day) | Other | Peanut Butter-Usual Diet, Usual Diet-Peanut Butter |
| Usual dietContinue intake of usual diet. | Other | Peanut Butter-Usual Diet, Usual Diet-Peanut Butter |
Primary outcome
Change in HbA1c
Time frame: 12 weeks
HbA1c will be assessed at the beginning and end of each 12-week period and expressed as percentage. The change in HbA1c will be calculated as the post-condition value minus the pre-condition value and expressed as percentage point change.
21 secondary outcomes
Change in fasting glucose
Time frame: 12 weeks
Change in fasting insulin
Time frame: 12 weeks
Mean glucose
Time frame: 12 weeks
Mean glucose time in range
Time frame: 12 weeks
Glycemic variability
Time frame: 12 weeks
Change in homeostatic model of insulin resistance (HOMA-IR)
Time frame: 12 weeks
Difference in ambulatory processing speed
Time frame: 12 weeks
Difference in ambulatory working memory
Time frame: 12 weeks
Difference in ambulatory attention
Time frame: 12 weeks
Change in body weight
Time frame: 12 weeks
Difference in hunger
Time frame: 12 weeks
Difference in satiety
Time frame: 12 weeks
Change in total cholesterol
Time frame: 12 weeks
Change in LDL-cholesterol
Time frame: 12 weeks
Change in triglycerides
Time frame: 12 weeks
Change in HDL-cholesterol
Time frame: 12 weeks
Change in non-HDL cholesterol
Time frame: 12 weeks
Change in central systolic and diastolic blood pressure
Time frame: 12 weeks
Change in peripheral systolic and diastolic blood pressure
Time frame: 12 weeks
Change in carotid-femoral pulse wave velocity
Time frame: 12 weeks
Change in diet quality
Time frame: 12 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 20 Jul 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 Peanut butter 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 29 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: opening soon, as of the sponsor's last update on 20 Jul 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 (+1 814 865 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: 12 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 20 Jul 2026.