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临床试验/NCT06348771
NCT06348771进行中(未招募)不适用

Postprandial Inflammation and PeaNuts in Older Adults

Rutgers, The State University of New Jersey4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
17
试验地点
4
主要终点
Concentration of Endotoxin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

盲法说明

No masking but participants are not told which foods in a given meal are higher in one fatty acid or another. 16 will be enrolled as per the sample size calculation for this study.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older adults across all racial/ethnic groups
  • Older men, and postmenopausal women > 2 years since last menses.

排除标准

  • 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.

研究组 & 干预措施

monounsaturated fatty acids (MUFA) peanut meal

Experimental

mixed meal test over 6 hours

干预措施: monounsaturated fatty acids (MUFA) peanut meal (Behavioral)

saturated fatty acids (SFA) meal

Active Comparator

mixed meal test over 6 hours

干预措施: monounsaturated fatty acids (MUFA) peanut meal (Behavioral)

结局指标

主要结局

Concentration of Endotoxin

时间窗: Change over 6 hour MMT

serum

次要结局

  • Concentration of Triglyceride(Change over 6 hour MMT)
  • Appetite(Change over 6 hour MMT)
  • Concentration of Glucose and Insulin(Change over 6 hour MMT)
  • Concentration of Inflammatory markers(Change over 6 hour MMT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sue A. Shapses, Ph.D., RD

Professor

Rutgers, The State University of New Jersey

研究点 (4)

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