Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348771
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-22
Brief Title:
Postprandial Inflammation and Nuts PIN in Older Adults
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Postprandial Inflammation and Peanuts in Older Adults
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIN
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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None