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临床试验/NCT03779321
NCT03779321已完成不适用

Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects

American University of Beirut Medical Center0 个研究点目标入组 30 人开始时间: 2016年9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
30
主要终点
GLP-1

研究概览

简要总结

Male subjects with specific body characteristics were recruited for the study. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.

详细描述

Male subjects were recruited for the study based on the following criteria: age between 18 and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take medications. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after a 3-day adaptation period. The meals had similar macronutrient composition and provided energy equivalent to 30% of the subjects' resting energy expenditure. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60, 120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Gender: Male
  • •Age: 18-50 years
  • •Body Mass Index (BMI): 18.5-24.9 kg/m2 or 30-39.9 kg/m2
  • •Stable body weight for at least three months before the study with the absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize the effect of weight change on ghrelin and GLP-1 statuses)
  • •Agreement on the acceptability levels of the two versions (high and low acceptability) of custard

排除标准

  • •Substance abuse such as alcohol or drugs
  • •Medical or psychological illness
  • •Previous gastrointestinal surgery
  • •History of weight fluctuation (weight loss of greater than 5% within the past 3 months)

研究组 & 干预措施

Lean panelists

Other

Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed

干预措施: Acceptability (Other)

Obese panelists

Other

Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed

干预措施: Acceptability (Other)

结局指标

主要结局

GLP-1

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

GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

Insulin

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

Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

Food acceptability

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

Food acceptability on a 9 point hedonic scale

Ghrelin

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

Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

Glucose

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

Glucose levels measured using VITROS ECiQ Immunodiagnostic System

次要结局

  • Appetite(Through study completion, an average of 1 year)
  • Energy intake at the next meal(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

Ammar Olabi

Professor

American University of Beirut Medical Center

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