Postprandial Inflammation and Nuts (PIN) in Older Adults

Overweight and Obesity Clinical Trial

— PIN  

Official title:

Postprandial Inflammation and PeaNuts in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348771
• Other study ID #: Pro2023001579
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Sue Shapses, PhD
• Phone: 8489329403
• Email: shapses[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: January 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Aging
• Inflammation
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• monounsaturated fatty acids (MUFA) peanut meal
mixed meal tolerance test and postprandial measurements

Locations

Country	Name	City	State
United States	Foran Hall	New Brunswick	New Jersey
United States	Rutgers University - NJ Inst Food Nutrition & Health	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of zonulin	serum permeability marker	Baseline only
Other	Lipid Profile	serum	Baseline only
Other	Characterization of the Microbiome	alpha and beta diversity of bacteria in feces	Baseline only
Other	Concentration of incretin hormones	serum GLP-1, gherlin, peptide YY (grams/volume)	Change over 6 hour MMT
Other	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
Primary	Concentration of Endotoxin	serum	Change over 6 hour MMT
Primary	Concentration of Interleukin-6	serum	Change over 6 hour MMT
Secondary	Concentration of Glucose and Insulin	serum (mg/dL)	Change over 6 hour MMT
Secondary	Concentration of Triglyceride	serum	Change over 6 hour MMT
Secondary	Appetite	visual analogue scale from 0 (not at all) to 14 (extremely)	Change over 6 hour MMT
Secondary	Concentration of Inflammatory markers	tumor necrosis factor-alpha, plasminogen activator inhibitor-1, lipopolysaccharide binding protein, hs-C reactive protein (grams/volume)	Change over 6 hour MMT