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临床试验/NCT02747446
NCT02747446已完成不适用

Effects of a Dietary Honey or Isomolar Fructose:Glucose Mixture on Glucose Tolerance and Blood Lipid Profile in Healthy Male Volunteers

Luc Tappy, MD1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
plasma total triglyceride profile

研究概览

简要总结

The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as acacia honey or a fructose:glucose mixture will be assessed in a group of healthy male volunteers. Primary outcome is plasma total triglyceride concentrations after ingestion of standardized breakfast and lunch containing 25% energy as honey or fructose:glucose mixture; secondary outcome is glucose tolerance and suppression of endogenous glucose production after ingestion of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose mixture diets will be compared to results obtained with a weight-maintenance, isocaloric diet in which starch is substituted for honey or fructose:glucose mixture

详细描述

Eight health males volunteers will be studied three times in a randomized order

  • Honey: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, 25% acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing honey; on day 8, they will have a 75g oral glucose4 + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
  • FG: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, and 25% of a fructose:glucose mixture matching the composition of acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing fructose and glucose; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
  • Control: volunteers will be fed a weight-maintenance diet containg 5% sugars, 45% starch, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch with no added sugar; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •health volunteer

排除标准

  • •BMI < 19.5
  • •BMI > 25
  • •Any disease
  • •current treatment with any drug

研究组 & 干预措施

control

No Intervention

no intervention: Diet with 45% starch and no honey or added sugars

Honey

Experimental

added sugar: diet with 25% acacia honey

干预措施: added sugar (Dietary Supplement)

Fructose:glucose mixture

Experimental

added sugar: Diet with 25% energy as a fructose:glucose mixture

干预措施: added sugar (Dietary Supplement)

结局指标

主要结局

plasma total triglyceride profile

时间窗: 7-day dietary intervention

plasma triglyceride concentrations measured before and after ingestion of a breakfast and a lunch

次要结局

  • glucose tolerance(7-day dietary intervention)

研究者

发起方
Luc Tappy, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luc Tappy, MD

Professor of Physiology

University of Lausanne

研究点 (1)

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