PrediabetesNCT06867198
Peanuts for Cardiometabolic, Brain, and Intestinal Health
A study testing Peanuts in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Georgia State University at 1 site in United States.
Trial summary
The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Cognition
- What is being tested?
- Peanuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 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 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- men and women
- 20-59 years of age
- BMI: 24.5 - 35.5 kg/m^2
- Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
- Ability to give consent
Who cannot join
- Allergies to peanuts and peanut products
- Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
- Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury
- Smoking
- Consumes greater than 2 alcoholic beverages per day
- Consumes antioxidant, probiotic, and prebiotic supplements
Show all 11Show fewer
- Pregnant or Lactating
- Actively participating in a weight loss program
- MRI Exclusion Criteria:
- Certain neurological disorders (e.g., uncontrolled seizure disorders)
- Braces on their teeth, a cardiac pacemaker; hearing aid; other metal in the body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects
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
Georgia State University
Atlanta, Georgia, 30303
Rafaela G Feresin, PhD, 404-413-1233, peanuts@gsu.edu
Rafaela G Feresin, PhD
About this study
Official title: Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations
The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.
Read the detailed description
In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.
- Conditions
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Cognition, Microvascular Function, Gut Microbiota, Endothelial Function (Reactive Hyperemia)
- Being tested
- Peanuts
- Keywords
- prediabetes, peanuts, functional foods, nuts, metabolic health, insulin resistance, type II diabetes, microvascular function, dietary intervention, cognitive function, vascular function, neuroimaging, endothelial function, cardiovascular health, gut microbiota
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance, Hyperemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeanutsDietary supplement
43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Peanut | Experimental | 43 g of peanut butter (1snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months Receives: Dietary Supplement: Peanuts |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measurement of fasting blood glucose
Measured: Baseline, 3 months, and 6 months
Glycosylated hemoglobin
Measurement of fasting glycosylated hemoglobin
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (15)
Ambulatory Blood Pressure
Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Measured: Baseline, 3 months, and 6 months
Fasting Insulin
Measurement of fasting insulin
Measured: Baseline, 3 months, and 6 months
Homeostasis model assessment-insulin resistance (HOMA-R)
Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405
Measured: Baseline, 3 months, and 6 months
Blood Lipid Profile
Measurement of blood lipid profile
Measured: Baseline, 3 months, and 6 months
Gut Microbiota Composition
Analysis of stool sample for determination of absolute levels of bacteria and relative species composition
Measured: Baseline, 3 months, and 6 months
Global Cognitive Ability
Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition
Measured: Baseline, 3 months, and 6 months
Performance Validity
Assessed using Rey 15
Measured: Baseline, 3 months, and 6 months
Verbal Memory & Recognition
Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms
Measured: Baseline, 3 months, and 6 months
Cognitive Inhibition
Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention
Measured: Baseline, 3 months, and 6 months
Cognitive Flexibility
Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching
Measured: Baseline, 3 months, and 6 months
Working Memory
Measured using Digit Span and NIH Toolbox List Sorting
Measured: Baseline, 3 months, and 6 months
Processing Speed
Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests
Measured: Baseline, 3 months, and 6 months
Associative Memory
Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests
Measured: Baseline, 3 months, and 6 months
Attention
Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1
Measured: Baseline, 3 months, and 6 months
Problem-Solving
Assessed using NIH Toolbox Visual Reasoning Test
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start6 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), The Peanut Institute
- Responsible party
- Principal investigator, Rafaela G. Feresin, Georgia State University
- Investigators
- Rafaela G Feresin, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867198
- Sponsor's protocol ID
- H25014
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations
- ClinicalTrials.gov ID
- NCT06867198
- Acronym / sponsor ID
- H25014
- Conditions
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Cognition, Microvascular Function, Gut Microbiota, Endothelial Function (Reactive Hyperemia)
- Keywords
- prediabetes, peanuts, functional foods, nuts, metabolic health, insulin resistance, type II diabetes, microvascular function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), The Peanut Institute
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Mar 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 overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.
Detailed description
In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut | Experimental | Dietary Supplement: Peanuts43 g of peanut butter (1snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- men and women
- 20-59 years of age
- BMI: 24.5 - 35.5 kg/m^2
- Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
- Ability to give consent
Key exclusion criteria (11 listed)
- Allergies to peanuts and peanut products
- Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
- Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury
- Smoking
- Consumes greater than 2 alcoholic beverages per day
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 |
|---|---|---|
| Peanuts43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months. | Dietary supplement | Peanut |
Primary outcome
Blood Glucose
Time frame: Baseline, 3 months, and 6 months
Measurement of fasting blood glucose
Glycosylated hemoglobin
Time frame: Baseline, 3 months, and 6 months
Measurement of fasting glycosylated hemoglobin
15 secondary outcomes
Ambulatory Blood Pressure
Time frame: Baseline, 3 months, and 6 months
Fasting Insulin
Time frame: Baseline, 3 months, and 6 months
Homeostasis model assessment-insulin resistance (HOMA-R)
Time frame: Baseline, 3 months, and 6 months
Blood Lipid Profile
Time frame: Baseline, 3 months, and 6 months
Gut Microbiota Composition
Time frame: Baseline, 3 months, and 6 months
Global Cognitive Ability
Time frame: Baseline, 3 months, and 6 months
Performance Validity
Time frame: Baseline, 3 months, and 6 months
Verbal Memory & Recognition
Time frame: Baseline, 3 months, and 6 months
Cognitive Inhibition
Time frame: Baseline, 3 months, and 6 months
Cognitive Flexibility
Time frame: Baseline, 3 months, and 6 months
Working Memory
Time frame: Baseline, 3 months, and 6 months
Processing Speed
Time frame: Baseline, 3 months, and 6 months
Associative Memory
Time frame: Baseline, 3 months, and 6 months
Attention
Time frame: Baseline, 3 months, and 6 months
Problem-Solving
Time frame: Baseline, 3 months, and 6 months
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 2 Sep 2026.
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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.
Rafaela G Feresin, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanuts in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Georgia 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 11 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 2 Sep 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 Rafaela G Feresin, PhD (404-413-1233, peanuts@gsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: Baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. 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 2 Sep 2026.