The Comparison of PYY, Ghrelin, GLP1, Glucose Level, VAS Level of Satiety, VAS Level of Hunger and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Ghrelin levels at 0 minute
研究概览
简要总结
Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger. Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. This study's objective is to compare the effect of breakfast with balance composition on gut hormones, glucose and ad libitum intake four hours after breakfast between obese and non obese..
The research methodology was used a clinical trial with 18 obese women and 22 non obese women participants. Subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat 22,6%). Gut hormones (PYY, Ghrelin, GLP -1) level , Glucose level and satiety 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
- Parallel
- 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 (for obese am)
- •BMI 18,5 - 23 (for NON- obese am)
- •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
Obese
Women age 20-40, with BMI ≥ 25-35 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity.
Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.
干预措施: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women (Behavioral)
Non Obese
Women age 20-40, with BMI 18,5-23 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity.
Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.
干预措施: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women (Behavioral)
结局指标
主要结局
Ghrelin levels at 0 minute
时间窗: baseline
analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.
Ghrelin levels at 15 minute
时间窗: 15 minutes
analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm.
Ghrelin levels at 60 minute
时间窗: 60 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm.
Ghrelin levels at 180 minute
时间窗: 180 minutes
analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
PYY levels at 0 minute
时间窗: baseline
analyzed by Radioimmunoassay, directly taken after having the breakfast with balance composition in both of the study arm
PYY levels at 15 minute
时间窗: 15 minutes
analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with balance composition in both of the study arm
Ghrelin levels at 120 minute
时间窗: 120 minutes
analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
PYY levels at 120 minute
时间窗: 120 minutes
analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 180 minute
时间窗: 180 minutes
analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
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 balanced composition in both of the study arm
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 balanced composition in both of the study arm
Ad Libitum intake
时间窗: 4 hours
Mean Ad Libitum intake (calories) in subjects four hours after breakfast with balance composition in both of the study arm
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 balance composition in both of the study arm
PYY levels at 180 minute
时间窗: 180 minutes
analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 15 minute
时间窗: 15 minutes
analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm
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 balance composition in both of the study arm
PYY levels at 60 minute
时间窗: 60 minutes
analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 120 minute
时间窗: 120 minutes
analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
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 balanced composition in both of the study arm
GLP-1 levels at 0 minute
时间窗: baseline
analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 60 minute
时间窗: 60 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm
Glucose levels at 0 minute
时间窗: baseline
analyzed by standard random glucose level from venous blood, directly taken after having the breakfast with balanced composition in both of the study arm
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 balanced composition in both of the study arm
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 balance composition in both of the study arm
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 balance composition in both of the study arm
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 balance composition in both of the study arm
VAS for satiety 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 balance composition in both of the study arm
VAS for satiety 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 balance composition in both of the study arm
VAS for satiety 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 balance composition in both of the study arm
VAS for satiety 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 balance composition in both of the study arm
VAS for satiety 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 balance composition in both of the study arm
次要结局
未报告次要终点
研究者
Fiastuti Witjaksono
Principal Investigator
Indonesia University