Postprandial Inflammation and Nuts (PIN) in Older Adults

NCT06348771 | Active Not Recruiting

• 1 other identifier: Pro2023001579
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Aging; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Concentration of Endotoxin

  serum

  Change over 6 hour MMT

Secondary Outcomes (4)

• Concentration of Glucose and Insulin

  Change over 6 hour MMT

• Concentration of Triglyceride

  Change over 6 hour MMT

• Appetite

  Change over 6 hour MMT

• Concentration of Inflammatory markers

  Change over 6 hour MMT

Other Outcomes (5)

• Concentration of zonulin

  Baseline only

• Lipid Profile

  Baseline only

• Characterization of the Microbiome

  Baseline only

Study Arms (2)

saturated fatty acids (SFA) meal

ACTIVE COMPARATOR

mixed meal test over 6 hours

Behavioral: monounsaturated fatty acids (MUFA) peanut meal

monounsaturated fatty acids (MUFA) peanut meal

EXPERIMENTAL

mixed meal test over 6 hours

Behavioral: monounsaturated fatty acids (MUFA) peanut meal

Interventions

monounsaturated fatty acids (MUFA) peanut meal BEHAVIORAL

mixed meal tolerance test and postprandial measurements

Also known as: Saturated fatty acid (SFA) meal

monounsaturated fatty acids (MUFA) peanut meal; saturated fatty acids (SFA) meal

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Foran Hall

New Brunswick, New Jersey, 08901, United States

Location

Rutgers University - NJ Inst Food Nutrition & Health

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Fatty Acids, Monounsaturated; Fatty Acids; Meals

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Unsaturated; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sue Shapses, PhD

  Rutgers, the State University of NJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 5, 2024
• Study Start: March 25, 2024
• Primary Completion: January 6, 2025
• Study Completion: May 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)