Postprandial Inflammation and Nuts (PIN) in Older Adults (PIN)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging; Overweight and Obesity
• Intervention / Treatment: Behavioral: monounsaturated fatty acids (MUFA) peanut meal

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers University - NJ Inst Food Nutrition & Health
    • New Brunswick, New Jersey, United States, 08901
      • Foran Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: saturated fatty acids (SFA) meal; mixed meal test over 6 hours	Behavioral: monounsaturated fatty acids (MUFA) peanut meal; mixed meal tolerance test and postprandial measurements; Other Names: Saturated fatty acid (SFA) meal
Experimental: monounsaturated fatty acids (MUFA) peanut meal; mixed meal test over 6 hours	Behavioral: monounsaturated fatty acids (MUFA) peanut meal; mixed meal tolerance test and postprandial measurements; Other Names: Saturated fatty acid (SFA) meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Endotoxin	serum	Change over 6 hour MMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Glucose and Insulin	serum (mg/dL)	Change over 6 hour MMT
Concentration of Triglyceride	serum	Change over 6 hour MMT
Appetite	visual analogue scale from 0 (not at all) to 14 (extremely)	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)	Change over 6 hour MMT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of zonulin	serum permeability marker	Baseline only
Lipid Profile	serum	Baseline only
Characterization of the Microbiome	alpha and beta diversity of bacteria in feces	Baseline only
Concentration of incretin hormones	serum GLP-1, gherlin, peptide YY (grams/volume)	Change over 6 hour MMT
Concentration of Bone regulating markers	Serum carboxyterminal crosslinking telopeptide of type I collagen (CTX), Procollagen type-I aminoterminal propeptide (PINP), Osteocalcin (grams/volume)	Fasting and change over 6 hour MMT

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Sue Shapses, PhD, Rutgers, the State University of NJ

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): October 7, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 30, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fatty Acids, Unsaturated; Meals; Fatty Acids, Monounsaturated; Fatty Acids
• Other Study ID Numbers: Pro2023001579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No