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Postprandial Inflammation and Nuts (PIN) in Older Adults

Postprandial Inflammation and Peanuts in Older Adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06348771
Acronym
PIN
Enrollment
17
Registered
2024-04-05
Start date
2024-03-25
Completion date
2025-10-07
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging, Overweight and Obesity

Brief 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 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.

Interventions

BEHAVIORALmonounsaturated fatty acids (MUFA) peanut meal

mixed meal tolerance test and postprandial measurements

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Masking description

No masking but participants are not told which foods in a given meal are higher in one fatty acid or another. 16 will be enrolled as per the sample size calculation for this study.

Intervention model description

Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Older adults across all racial/ethnic groups * Older men, and postmenopausal women \> 2 years since last menses.

Exclusion criteria

* 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 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Concentration of EndotoxinChange over 6 hour MMTserum

Secondary

MeasureTime frameDescription
Concentration of Glucose and InsulinChange over 6 hour MMTserum (mg/dL)
Concentration of TriglycerideChange over 6 hour MMTserum
AppetiteChange over 6 hour MMTvisual analogue scale from 0 (not at all) to 14 (extremely)
Concentration of Inflammatory markersChange over 6 hour MMTInterleukin-6, tumor necrosis factor-alpha, plasminogen activator inhibitor-1, lipopolysaccharide binding protein, hs-C reactive protein (grams/volume)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSue Shapses, PhD

Rutgers, the State University of NJ

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026