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临床试验/NCT06495255
NCT06495255招募中不适用

Bioavailability of Human Milk Oligosaccharides in Healthy Adults

University of Bonn2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Absorption of HMOs

研究概览

简要总结

Human milk oligosaccharides (HMOs) have been associated with beneficial health outcomes in breastfed infants, therefore they were investigated intensively within recent years. HMOs support the establishment of a "balanced" intestinal microbiome by acting as both a prebiotic and as a specific antimicrobial. In vitro work has demonstrated that HMOs are resistant to hydrolysis by salivary, pancreatic, and brush-border enzymes, as well as to low gastric pH values enzymes. Consequently, HMOs are mostly resistant to digestion and reach the colon unmodified, where they are available for selective utilisation by certain bacteria. Microbial utilisation results in the formation of microbial metabolites, which are associated with local and systemic effects. Simultaneously, HMOs have bacteriostatic effects and directly limit the growth of potential pathogens. Moreover, they serve as antiadhesives, mimicking intestinal epithelial cell surface receptors to which pathogenic microbes attach, thus acting as a decoy receptor. Additionally, it is suggested that HMOs exert effects independent of the microbiome, by modulating cell recognition and cell signalling. These include interactions with immune cells, thereby modulating the development and responses of the immune system, the maturation of the intestinal glycocalyx, and the promotion of neurodevelopment and cognitive functions. A prerequisite for systemic effects is that HMOs are absorbed and can enter the blood circulation, thus making them potentially available at the systemic level. In order to understand the underlying mechanisms for HMO-mediated, microbe-independent effects, information regarding absorption, metabolisation, and excretion is needed and will be investigated in this study.

研究设计

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

盲法说明

Participants are blinded to the supplement.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-40 Years
  • Non-smoker
  • Normal weight (BMI 18.5-25.0 kg/m²)

排除标准

  • Impaired insulin sensitivity/glucose tolerance
  • Underweight or overweight/obesity
  • Regular intake of nutritional supplements
  • Alcohol, drug or medication abuse
  • Pregnancy and breastfeeding
  • Hypo- and hypertension
  • known hepatitis B, hepatitis C, HIV infection
  • Malabsorption and maldigestion syndrome
  • Type 1 or type 2 diabetes mellitus
  • Other metabolic diseases
  • Chronic inflammatory diseases
  • Other chronic diseases
  • Psychiatric illnesses
  • Participation in another study

结局指标

主要结局

Absorption of HMOs

时间窗: through study completion, an average of 1 year

Concentration of HMOs in blood

Excretion of HMOs

时间窗: through study completion, an average of 1 year

Concentration of HMOs in urine

次要结局

  • Metabolism(through study completion, an average of 1 year)

研究者

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

Marie-Christine Simon, PhD MSc RD

Jun. Prof. Dr. Marie-Christine Simon (PI)

University of Bonn

研究点 (2)

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