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临床试验/NCT01297738
NCT01297738已完成不适用

The Effect of Dietary Patterns and Diet Composition on Insulin Sensitivity and Cerebral Dopamine- and Serotonin Transporters

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2011年2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
入组人数
39
试验地点
1
主要终点
Cerebral binding of [123I]FP-CIT to serotonin- and dopamine transporters and correlation with changes in in vivo and ex vivo insulin sensitivity

研究概览

简要总结

Obesity and insulin resistance may be in part explained by an altered reward system with changes in the serotonin/dopamine system. These changes might be caused by changes in dietary habits, especially by an increased intake of liquid sugar and an increase in meal frequency. The investigators hypothesize that increasing meal frequency compared to increasing meal size and when consuming a hypercaloric high-sugar diet (HS) compared to a hypercaloric high-fat-high-sugar diet (HFHS) will result in a reduction in cerebral serotonin and dopamine transporters and in a more prominent increase in insulin resistance. In addition, the investigators hypothesize that the changes in insulin sensitivity will be independent of changes in abdominal (visceral) and liver fat and that changes in insulin sensitivity due to the dietary manipulation will co-occur with changes in insulin signaling pathways in peripheral fat and muscle tissue.

详细描述

Lean, healthy, young men will follow a hypercaloric HF- or HFHS diet for 6 weeks. Before and after the dietary intervention, the investigators will perform a SPECT-scan for serotonin and dopamine transporters with the radioligand [123I]FP-CIT, administered intravenously. The investigators will also perform a structural MRI for localization. Furthermore the investigators will perform a liver MRS and abdominal MRI for liver fat- and abdominal visceral fat measurement. The investigators will also perform a euglycemic, hyperinsulinemic clamp to measure insulin sensitivity and muscle- and fat biopsies to examine changes in insulin signaling pathways and fat metabolism. After the hypercaloric diet subjects will follow a hypocaloric diet until their weight is back to baseline.

研究设计

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

入排标准

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

入选标准

  • •BMI 19-26 kg/m2
  • •Age 18-40 years old
  • •Male gender
  • •Caucasian
  • •Stable weight 3 months prior to start study participation

排除标准

  • •Abnormal oral glucose tolerance test (OGTT)
  • •Lipid disorders, renal disorders, thyroid disorders, elevated liver enzymes
  • •Use of medication
  • •Use of alcohol > 3/day
  • •Use of ecstasy, amphetamines or cocaine
  • •History of eating disorder or psychiatric disorder
  • •Any medical condition, intensive sports ( >3 times/week), shift work

研究组 & 干预措施

Meal size increase with HFHS

Experimental

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a liquid meal which is high in fat and sugar (Nutridrink®)

干预措施: Meal size increase with HFHS (Other)

Meal size increase with HS

Experimental

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume this caloric surplus with their meals, which results in an increase in meal size.

干预措施: Meal size increase with HS (Other)

Meal frequency increase with HFHS

Experimental

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a liquid meal which has a high fat and sugar content(Nutridrink®). Subjects consume the Nutridrink 3 times a day in between meals. which results in an increase in meal frequency.

干预措施: Meal frequency increase with HFHS (Other)

Meal frequency increase with HS

Experimental

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages 3 times a day in between meals, which results in an increase in meal frequency.

干预措施: Meal frequency increase with HS (Other)

Control group

No Intervention

Subjects will not follow any diet but their own ad-libitum, healty diet.

结局指标

主要结局

Cerebral binding of [123I]FP-CIT to serotonin- and dopamine transporters and correlation with changes in in vivo and ex vivo insulin sensitivity

时间窗: At baseline and after 6 weeks of hypercaloric HFHS or HS diet

Difference in cerebral binding of the radioligand \[123I\]FP-CIT to serotonin- and dopamine transporters before and after dietary manipulations and correlation of cerebral dopamine and serotonin transporter binding with changes in in vivo and ex vivo insulin sensitivity.

次要结局

  • Abdominal fat mass(At baseline and after 6 weeks of HFHS or HS hypercaloric diet)
  • Glucoregularoty hormones(At baseline and after 6 weeks of hypercaloric HFHS- or HS diet)
  • Insulin signalling pathways(At baseline and after 6 weeks of hypercaloric HFHS- or HS diet)

研究者

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

K.E.M. Koopman

ms

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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