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临床试验/NCT03387293
NCT03387293已完成不适用

Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

TC Erciyes University0 个研究点目标入组 22 人开始时间: 2016年11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
22
主要终点
Postprandial insulin response

研究概览

简要总结

The aim of this study was to determine the effect of food insulin index (FII) on metabolic parameters and appetite in obese adolescents with insulin resistance. A randomized, single-blind and crossover trial included 15 obese adolescents aged 12-18 years with insulin resistance. All participants were submitted two different breakfasts: low glycemic index, low insulin index (LGI-LII) and low glycemic index, high insulin index (LGI-HII), with a 1-week washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180 and 240 minutes after the meal, serum glucose, insulin and c-peptide levels were measured and appetite was evaluated by visual analog scale. At the end of four hours, participants were served ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Participant)

入排标准

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

入选标准

  • Aged 12-18 years
  • Age- and sex-specific body mass index (BMI) ≥95th percentile of the World Health Organization (WHO) growth-reference data
  • New diagnosis and not receiving any treatment
  • Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) >3.16

排除标准

  • Hypertension, cardiovascular disease, diabetes mellitus or any other significant metabolic, endocrine or gastrointestinal disease
  • Use of tobacco or alcohol
  • Taking any medications
  • Having difficulties for physical activity

研究组 & 干预措施

LGI-LII Breakfast

Experimental

Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal

干预措施: LGI-LII Breakfast (Other)

LGI-LII Breakfast

Experimental

Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal

干预措施: LGI-HII Breakfast (Other)

LGI-HII Breakfast

Experimental

Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal

干预措施: LGI-LII Breakfast (Other)

LGI-HII Breakfast

Experimental

Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal

干预措施: LGI-HII Breakfast (Other)

结局指标

主要结局

Postprandial insulin response

时间窗: Four hours postprandial period

Postprandial insulin response was quantified as AUC (μU/mL x minutes), which was calculated according to the trapezoidal rule by using serum insulin values at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes.

Postprandial glucose response

时间窗: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

Postprandial glucose response was quantified as area under the curve (AUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes.

Postprandial C-peptide response

时间窗: Four hours postprandial period

Postprandial C-peptide response was quantified as AUC (ng/mL x minutes), which was calculated according to the trapezoidal rule by using serum C-peptide values at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes.

次要结局

  • Hunger rating(Four hours postprandial period)
  • Desiring for salty(Four hours postprandial period)
  • Desiring for fatty(Four hours postprandial period)
  • Smell of test meal(Immediately after consuming test meal (at 15 minutes))
  • Fullness rating(Four hours postprandial period)
  • Desiring for sweet(Four hours postprandial period)
  • Desiring for savoury(Four hours postprandial period)
  • Desiring to eat(Four hours postprandial period)
  • Subsequent energy consumption(Four hours after consuming test meal (at 240 minutes))
  • Visual appeal of test meal(Immediately after consuming test meal (at 15 minutes))
  • Taste of test meal(Immediately after consuming test meal (at 15 minutes))
  • Palatability of test meal(Immediately after consuming test meal (at 15 minutes))
  • Prospective food consumption(Four hours postprandial period)
  • Aftertaste of test meal(Immediately after consuming test meal (at 15 minutes))

研究者

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

Zeynep Caferoglu, PhD

Assistant Professor Doctor

TC Erciyes University

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