The Effect of Breakfast With Different Macronutrient Composition on PYY, Ghrelin, GLP-1, Glucose Level, VAS for Hunger, VAS for Satiety and Ad Libitum Intake 4 Hours After Breakfast in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ad Libitum intake
研究概览
简要总结
Gut hormones, such as PYY and ghrelin, are associated with appetite control and obesity. Protein is thought to be the most satieting nutrient and could affect production of several gut hormones. This study's objective is to find the effect of breakfast with different protein composition on PYY, ghrelin, and ad libitum intake four hours after breakfast.
The research methodology was used a clinical trial with 22 obese women participants. Subjects were given three types of breakfast: low protein consumption (12.4% protein), medium protein (23.5% protein), and high protein (40,6% protein). PYY and ghrelin level were measured at 0, 15, 60, 120, and 180 minutes after breakfast. Ad libitum meal was given four hours after breakfast and measured after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 25-30 (obese)
- •with stable body weight within the last 6 months (body weight change less than 4 kg)
- •normal blood glucose level.
排除标准
- •patients who never had breakfast
- •patients in weight loss program
- •patients consuming lipid-absorption inhibitor or appetite-suppressing drugs
- •patients that have had gastrointestinal tract resection.
研究组 & 干预措施
High Protein
(40,6% protein)
干预措施: diet with different composition (Behavioral)
Moderate Protein
(23.5% protein)
干预措施: diet with different composition (Behavioral)
Low Protein
(12.4% protein)
干预措施: diet with different composition (Behavioral)
结局指标
主要结局
Ad Libitum intake
时间窗: 4 hours
Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition
Ghrelin levels at 180 minute
时间窗: 180 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
PYY levels at 15 minute
时间窗: 15 minutes
analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition
GLP-1 levels at 0 minute
时间窗: baseline
analyzed by ELISA, directly taken after having the breakfast with different protein composition
Glucose levels at 60 minute
时间窗: 60 minutes
analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with different protein composition
Ghrelin levels at 60 minute
时间窗: 60 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Ghrelin levels at 120 minute
时间窗: 120 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
PYY levels at 0 minute
时间窗: baseline
analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition
PYY levels at 60 minute
时间窗: 60 minutes
analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition
GLP-1 levels at 120 minute
时间窗: 120 minutes
analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition
Ghrelin levels at 0 minute
时间窗: baseline
analyzed by ELISA, directly taken after having the breakfast with different protein composition
Ghrelin levels at 15 minute
时间窗: 15 minutes
analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
PYY levels at 180 minute
时间窗: 180 minutes
analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition
Glucose levels at 0 minute
时间窗: baseline
analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition
Glucose levels at 15 minute
时间窗: 15 minutes
analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with different protein composition
Glucose levels at 120 minute
时间窗: 120 minutes
analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with different protein composition
VAS for hunger at 15 minutes
时间窗: 15 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 15 minutes after having the breakfast with different protein composition
VAS for hunger at 120 minutes
时间窗: 120 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 120 minutes after having the breakfast with different protein composition
VAS for hunger at 180 minutes
时间窗: 180 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 180 minutes after having the breakfast with different protein composition
PYY levels at 120 minute
时间窗: 120 minutes
analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition
Glucose levels at 180 minute
时间窗: 180 minutes
analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with different protein composition
VAS for hunger at 60 minutes
时间窗: 60 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 60 minutes after having the breakfast with different protein composition
VAS for satiety at 0 minute
时间窗: baseline
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken directly after having the breakfast with different protein composition
GLP-1 levels at 15 minute
时间窗: 15 minutes
analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
GLP-1 levels at 60 minute
时间窗: 60 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
GLP-1 levels at 180 minute
时间窗: 180 minutes
analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition
VAS for hunger at 0 minutes
时间窗: baseline
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), directly taken after having the breakfast with different protein composition
VAS for satiety at 15 minute
时间窗: 15 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 15 minutes after having the breakfast with different protein composition
VAS for satiety at 60 minute
时间窗: 60 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 60 minutes after having the breakfast with different protein composition
VAS for satiety at 180 minute
时间窗: 180 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 180 minutes after having the breakfast with different protein composition
VAS for satiety at 120 minute
时间窗: 120 minutes
Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 120 minutes after having the breakfast with different protein composition
次要结局
未报告次要终点
研究者
Fiastuti Witjaksono
Principal Investigator
Indonesia University