Postprandial Inflammation and Nuts (PIN) in Older Adults

Not Applicable

Active, not recruiting

• Conditions: Healthy Aging; Overweight and Obesity
• Interventions: Behavioral: monounsaturated fatty acids (MUFA) peanut meal

• Registration Number: NCT06348771
• Lead Sponsor: Rutgers, The State University of New Jersey

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. 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 Timeline

• Study First Submitted: 2024-03-22
• Study Start: 2024-03-25
• Study First Submitted QC: 2024-03-30
• Study First Posted: 2024-04-05
• Status Verified: 2025-01
• Primary Completion: 2025-01-06
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
monounsaturated fatty acids (MUFA) peanut meal	monounsaturated fatty acids (MUFA) peanut meal	mixed meal test over 6 hours
saturated fatty acids (SFA) meal	monounsaturated fatty acids (MUFA) peanut meal	mixed meal test over 6 hours

Primary Outcome Measures

Name	Time	Method
Concentration of Endotoxin	Change over 6 hour MMT	serum

Secondary Outcome Measures

Name	Time	Method
Concentration of Glucose and Insulin	Change over 6 hour MMT	serum (mg/dL)
Concentration of Triglyceride	Change over 6 hour MMT	serum
Appetite	Change over 6 hour MMT	visual analogue scale from 0 (not at all) to 14 (extremely)
Concentration of Inflammatory markers	Change over 6 hour MMT	Interleukin-6, tumor necrosis factor-alpha, plasminogen activator inhibitor-1, lipopolysaccharide binding protein, hs-C reactive protein (grams/volume)

Trial Locations

Locations (2)

Foran Hall; 🇺🇸 New Brunswick, New Jersey, United States

Rutgers University - NJ Inst Food Nutrition & Health; 🇺🇸 New Brunswick, New Jersey, United States