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临床试验/NCT04924530
NCT04924530Unknown不适用

Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia

University of Bath2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Postprandial Changes in Plasma Triglyceride Concentrations

研究概览

简要总结

This study aims to determine to what extent ingestion of free sugars influence postprandial triglyceridaemia in men and women.

详细描述

Each participant will undergo three experimental trials in a randomized, crossover research design. On each study day, participants will consume a test drink containing standardised amounts of carbohydrate and fat followed by collection of blood and breath samples to assess metabolic responses during the 6 hour postprandial period. Trials will be identical except for the type of carbohydrate contained within the test drink: 1) maltodextrin (glucose polymer), 2) lactose (galactose-glucose disaccharide) and 3) sucrose (fructose-glucose disaccharide).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-50 years and premenopausal (for women)
  • Exclusion criteria:
  • Weight instability (>5 kg change in body mass within last 6 months)
  • Diagnosis of any form of diabetes
  • Intolerances or allergies to any of the study procedures (e.g. lactose intolerance)
  • Galactose disorders (e.g. galactokinase deficiency, UDPgalactose-4-epimerase deficiency, galactose-1-phosphate uridyl transferase deficiency)
  • Fructose malabsorption
  • Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
  • Pregnant or lactating
  • Any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).

排除标准

  • 未提供

结局指标

主要结局

Postprandial Changes in Plasma Triglyceride Concentrations

时间窗: 6 hours

Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes

次要结局

  • Postprandial de Novo Lipogenesis (DNL)(6 hours)
  • Dietary Fat Oxidation(6 hours)
  • Postprandial Changes in Plasma Insulin Concentrations(6 hours)
  • Postprandial Changes in Plasma Glucose Concentrations(6 hours)
  • Postprandial Changes in Plasma Galactose Concentrations(6 hours)
  • Postprandial Changes in Plasma Fructose Concentrations(6 hours)
  • Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations(6 hours)
  • Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations(6 hours)
  • Postprandial Changes in Plasma Lactate Concentrations(6 hours)
  • Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations(6 hours)
  • Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations(6 hours)
  • Postprandial Changes in Plasma Uric Acid Concentrations(6 hours)

研究者

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

Steven Carter

Research Associate

University of Bath

研究点 (2)

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