Clinical trial NCT06348771: Postprandial Inflammation and Nuts (PIN) in Older Adults
Official title: Postprandial Inflammation and Peanuts in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Overweight and Obesity
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 17
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese
Primary purpose: PREVENTION

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of Endotoxin
timeFrame: Change over 6 hour MMT
Secondary outcomes:
measure: Concentration of Glucose and Insulin
timeFrame: Change over 6 hour MMT
measure: Concentration of Triglyceride
timeFrame: Change over 6 hour MMT
measure: Appetite
timeFrame: Change over 6 hour MMT
measure: Concentration of Inflammatory markers
timeFrame: Change over 6 hour MMT
Other outcomes:
measure: Concentration of zonulin
timeFrame: Baseline only
measure: Lipid Profile
timeFrame: Baseline only
measure: Characterization of the Microbiome
timeFrame: Baseline only
measure: Concentration of incretin hormones
timeFrame: Change over 6 hour MMT
measure: Concentration of Bone regulating markers
timeFrame: Fasting and change over 6 hour MMT
Locations:
city: New Brunswick
country: United States
facility: Foran Hall
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers University - NJ Inst Food Nutrition & Health
state: New Jersey
Study officials:
affiliation: Rutgers, the State University of NJ
name: Sue Shapses, PhD
role: PRINCIPAL_INVESTIGATOR
References: