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Postprandial Inflammation and Nuts (PIN) in Older Adults

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Active, not recruiting

Conditions

Overweight and Obesity
Healthy Aging

Treatments

Behavioral: monounsaturated fatty acids (MUFA) peanut meal

Study type

Interventional

Funder types

Other

Identifiers

NCT06348771
Pro2023001579

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

17 participants in 2 patient groups

saturated fatty acids (SFA) meal
Active Comparator group
Description:
mixed meal test over 6 hours
Treatment:
Behavioral: monounsaturated fatty acids (MUFA) peanut meal
monounsaturated fatty acids (MUFA) peanut meal
Experimental group
Description:
mixed meal test over 6 hours
Treatment:
Behavioral: monounsaturated fatty acids (MUFA) peanut meal

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Rebecca Serrano, MPH, RD; Sue Shapses, PhD

Data sourced from clinicaltrials.gov

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