Healthy AgingPINNCT06348771
Postprandial Inflammation and Nuts (PIN) in Older Adults
A study testing monounsaturated fatty acids (MUFA) peanut meal in people with Healthy Aging and Overweight and Obesity, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Overweight and Obesity
- What is being tested?
- monounsaturated fatty acids (MUFA) peanut meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2024to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults across all racial/ethnic groups
- Older men, and postmenopausal women > 2 years since last menses.
Who cannot join
- Anemia
- Diagnosed with, active, or history of liver cirrhosis, chronic or persisting hepatitis
- Diagnosed with, active, or history of cancer
- History of gastrointestinal disease or surgical procedure for weight loss.
- Diagnosed with immune diseases, type 1 or 2 diabetes, pancreatitis, metabolic bone disease or infectious diseases
- Any surgery in the past 6 months
Show all 12Show fewer
- Currently using or have used antibiotics continuously > 3 days in the past 3 months
- Regular use of medications for that affect the gastrointestinal tract, cholecystitis, urinary tract infection, significant renal disease, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS
- Known allergy or intolerance to any ingredients in the meal intervention
- Recent colonoscopy (within the previous two months)
- Uncontrolled hypertension or uncontrolled severe hyperlipidemia.
- Participation in another clinical research trial that may interfere with the results of this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Foran Hall
New Brunswick, New Jersey, 08901
Rutgers University - NJ Inst Food Nutrition & Health
New Brunswick, New Jersey, 08901
About this study
Official title: Postprandial Inflammation and Peanuts in Older Adults
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults.
Read the detailed description
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. Given these findings, this study will address the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and the serum endotoxin (lipopolysaccharide, LPS) postprandial response will be compared to a high SFA meal. Baseline measurements will include body composition and serum lipids and glucose. The objectives of the study are: 1. To determine the endotoxin and inflammatory response to a meal with two levels of saturated fat in older individuals with overweight or obesity using a randomized cross-over design; 2. To evaluate satiety and fullness in response to the two meals. It is hypothesized that postprandial circulating endotoxin and inflammation will be higher, and satiety will be similar after the SFA enriched compared to the lower SFA (peanut based) meal. A sample size analysis indicates that 16 participants are needed (α set at 0.05, and power set at 90%) to detect a significant difference in endotoxin between groups. Assuming a 10% dropout, up to 18 individuals will be enrolled. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults.
- Conditions
- Healthy Aging, Overweight and Obesity
- Being tested
- monounsaturated fatty acids (MUFA) peanut meal
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monounsaturated fatty acids (MUFA) peanut mealBehavioural
Also called Saturated fatty acid (SFA) meal
mixed meal tolerance test and postprandial measurements
| Study group | Role | What they receive |
|---|---|---|
| saturated fatty acids (SFA) meal | Active comparator | mixed meal test over 6 hours Receives: Behavioral: monounsaturated fatty acids (MUFA) peanut meal |
| monounsaturated fatty acids (MUFA) peanut meal | Experimental | mixed meal test over 6 hours Receives: Behavioral: monounsaturated fatty acids (MUFA) peanut meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Endotoxin
serum
Measured: Change over 6 hour MMT
Secondary outcomes (4)
Concentration of Glucose and Insulin
serum (mg/dL)
Measured: Change over 6 hour MMT
Concentration of Triglyceride
serum
Measured: Change over 6 hour MMT
Appetite
visual analogue scale from 0 (not at all) to 14 (extremely)
Measured: Change over 6 hour MMT
Concentration of Inflammatory markers
Interleukin-6, tumor necrosis factor-alpha, plasminogen activator inhibitor-1, lipopolysaccharide binding protein, hs-C reactive protein (grams/volume)
Measured: Change over 6 hour MMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start25 Mar 2024
- Primary completion6 Jan 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Model description
- Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue A. Shapses, Ph.D., RD, Rutgers, The State University of New Jersey
- Investigators
- Sue Shapses, PhD, Principal investigator, Rutgers, the State University of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348771
- Sponsor's protocol ID
- Pro2023001579
- Acronym
- PIN
- Status last verified
- May 2026
- First submitted
- 22 Mar 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Inflammation and Peanuts in Older Adults
- ClinicalTrials.gov ID
- NCT06348771
- Acronym / sponsor ID
- PIN / Pro2023001579
- Conditions
- Healthy Aging, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 5 Apr 2024 (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 aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults.
Detailed description
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. Given these findings, this study will address the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and the serum endotoxin (lipopolysaccharide, LPS) postprandial response will be compared to a high SFA meal. Baseline measurements will include body composition and serum lipids and glucose. The objectives of the study are: 1. To determine the endotoxin and inflammatory response to a meal with two levels of saturated fat in older individuals with overweight or obesity using a randomized cross-over design; 2. To evaluate satiety and fullness in response to the two meals. It is hypothesized that postprandial circulating endotoxin and inflammation will be higher, and satiety will be similar after the SFA enriched compared to the lower SFA (peanut based) meal. A sample size analysis indicates that 16 participants are needed (α set at 0.05, and power set at 90%) to detect a significant difference in endotoxin between groups. Assuming a 10% dropout, up to 18 individuals will be enrolled. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese
| Arm | Type | Receives |
|---|---|---|
| saturated fatty acids (SFA) meal | Active comparator | Behavioral: monounsaturated fatty acids (MUFA) peanut mealmixed meal test over 6 hours |
| monounsaturated fatty acids (MUFA) peanut meal | Experimental | Behavioral: monounsaturated fatty acids (MUFA) peanut mealmixed meal test over 6 hours |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older adults across all racial/ethnic groups
- Older men, and postmenopausal women > 2 years since last menses.
Key exclusion criteria (12 listed)
- Anemia
- Diagnosed with, active, or history of liver cirrhosis, chronic or persisting hepatitis
- Diagnosed with, active, or history of cancer
- History of gastrointestinal disease or surgical procedure for weight loss.
- Diagnosed with immune diseases, type 1 or 2 diabetes, pancreatitis, metabolic bone disease or infectious diseases
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 |
|---|---|---|
| monounsaturated fatty acids (MUFA) peanut mealAlso: Saturated fatty acid (SFA) mealmixed meal tolerance test and postprandial measurements | Behavioural | monounsaturated fatty acids (MUFA) peanut meal, saturated fatty acids (SFA) meal |
Primary outcome
Concentration of Endotoxin
Time frame: Change over 6 hour MMT
serum
4 secondary outcomes
Concentration of Glucose and Insulin
Time frame: Change over 6 hour MMT
Concentration of Triglyceride
Time frame: Change over 6 hour MMT
Appetite
Time frame: Change over 6 hour MMT
Concentration of Inflammatory markers
Time frame: Change over 6 hour MMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).
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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. This study is not recruiting at the moment.
Sue Shapses, PhD principal investigator
Rutgers, the State University of NJ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monounsaturated fatty acids (MUFA) peanut meal in people with Healthy Aging and Overweight and Obesity, run by Rutgers, The State University of New Jersey at 2 sites 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 13 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Endotoxin (time frame: Change over 6 hour MMT). 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 13 May 2026.