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临床试验/NCT07125001
NCT07125001招募中不适用

The Influence of Mango-Derived Intestinal Microbial Metabolites on Gut Permeability, Inflammation, and Cardiometabolic Health Markers in Hispanic/Latino Adolescents

University of California, Davis1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Microvascular Function

研究概览

简要总结

Mangos contain a number of nutrients that may improve gut and metabolic health. The purpose of this research is to see how eating mangos every day for 4 weeks instead of snacks high in calories and low in nutrients such as cookies, crackers, chips, and candy can impact adolescent health.

详细描述

This study will record the functional and metabolic effects of daily mango intake, incorporated into the habitual diets of Hispanic/Latino adolescent children. This racial group is considered the most significant minority in the US, accounting for 19.1% of the population. The proposed study design allows for comparing baseline metabolic and physiological function to the real-world situation of adding a new snack food to a child in the major minority group in the US habitual diet. Moreover, the study design will allow the assessment of dietary changes in an understudied population at increased cardiovascular risk due to the high prevalence of overweight and obesity. Collectively, these analyses will help identify the complex relationships of mango-derived nutrients and microbial metabolites to physiologic response.

Twenty-five (12-19 years of age) adolescents will be enrolled in a randomized, controlled 2-arm crossover dietary intervention trial. Participants will be randomized to consume either ¾ cups of mango or continue their habitual diet for 4 weeks, followed by a 4-week washout period before crossing over to the alternate group. The mango flesh will be cut into uniform chunks (2-3 cm) and portioned into individual servings that can be consumed either as-is or blended into a smoothie.

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
None

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - Male or Female 12-19 years old
  • BMI ≥ 85th percentile (https://www.bcm.edu/bodycomplab/BMIapp/BMI-calculator-kids.html)
  • Self-reported Hispanic/Latino
  • Subject is willing and able to comply with the study protocols
  • Subject is willing to consume the test products
  • Female-specific criteria: if menstruating, eumenorrheic (regular monthly menstrual cycles of 25-30-days in length)
  • Access to a smartphone or tablet at least 1x / day and willing to take pictures associated with the products to be consumed in the study

排除标准

  • - Reported food allergies.
  • Currently taking prescription drugs, with the exception of asthma inhalers, which are allowed
  • BMI <85th percentile (https://www.bcm.edu/bodycomplab/BMIapp/BMI-calculator-kids.html)
  • Current participation in a moderate or high-intensity daily exercise routine
  • Self-reported disease, serious illness, or who are currently under acute medical care.
  • Currently taking prescription drugs.
  • Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements, and not willing to discontinue before starting the study.
  • Vegetarian or vegan diet
  • Self-reported malabsorption or gastrointestinal issues
  • Fruit and vegetable intake exceeding daily recommendations of 5 servings
  • Smoking (vaping, conventional nicotine-containing products or marijuana)
  • Current enrollee in a clinical research study

研究组 & 干预措施

Mango arm

Experimental

Ataulfo Mango intake

干预措施: Ataulfo mango (Other)

No mango intake

No Intervention

4 weeks of no mango intake

结局指标

主要结局

Microvascular Function

时间窗: 4 weeks

Microvascular function as measured by peripheral arterial tonometry (ENDO PAT 2000)

次要结局

  • Bile acids(4 weeks)
  • zonulin(4 weeks)
  • Cytokines(4 weeks)
  • short chain fatty acids(4 weeks)
  • soluble lipopolysaccharide binding protein(4 weeks)
  • cd14(4 weeks)
  • GLP-1(4 weeks)
  • plasma lipids(4 weeks)
  • IGF/IGFbp(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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