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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06348771
Other study ID # Pro2023001579
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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