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临床试验/NCT06867198
NCT06867198招募中不适用

Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations

Georgia State University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Blood Glucose

研究概览

简要总结

The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.

详细描述

In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • men and women
  • 20-59 years of age
  • BMI: 24.5 - 35.5 kg/m^2
  • Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
  • Ability to give consent

排除标准

  • Allergies to peanuts and peanut products
  • Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
  • Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury
  • Consumes greater than 2 alcoholic beverages per day
  • Consumes antioxidant, probiotic, and prebiotic supplements
  • Pregnant or Lactating
  • Actively participating in a weight loss program
  • MRI Exclusion Criteria:
  • Certain neurological disorders (e.g., uncontrolled seizure disorders)
  • Braces on their teeth, a cardiac pacemaker; hearing aid; other metal in the body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects

研究组 & 干预措施

Peanut

Experimental

43 g of peanut butter (1snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months

干预措施: Peanuts (Dietary Supplement)

Control

No Intervention

No intervention

结局指标

主要结局

Blood Glucose

时间窗: Baseline, 3 months, and 6 months

Measurement of fasting blood glucose

Glycosylated hemoglobin

时间窗: Baseline, 3 months, and 6 months

Measurement of fasting glycosylated hemoglobin

次要结局

  • Ambulatory Blood Pressure(Baseline, 3 months, and 6 months)
  • Fasting Insulin(Baseline, 3 months, and 6 months)
  • Homeostasis model assessment-insulin resistance (HOMA-R)(Baseline, 3 months, and 6 months)
  • Working Memory(Baseline, 3 months, and 6 months)
  • Cognitive Flexibility(Baseline, 3 months, and 6 months)
  • Blood Lipid Profile(Baseline, 3 months, and 6 months)
  • Gut Microbiota Composition(Baseline, 3 months, and 6 months)
  • Global Cognitive Ability(Baseline, 3 months, and 6 months)
  • Performance Validity(Baseline, 3 months, and 6 months)
  • Verbal Memory & Recognition(Baseline, 3 months, and 6 months)
  • Cognitive Inhibition(Baseline, 3 months, and 6 months)
  • Processing Speed(Baseline, 3 months, and 6 months)
  • Associative Memory(Baseline, 3 months, and 6 months)
  • Attention(Baseline, 3 months, and 6 months)
  • Problem-Solving(Baseline, 3 months, and 6 months)

研究者

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

Rafaela G. Feresin

Associate Professor

Georgia State University

研究点 (2)

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