A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in Pizza Consumed During Two Meals
研究概览
简要总结
The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce appetite and hunger given on the same day of testing.
详细描述
Four hours after breakfast a small amount of liquid to drink will be given to a participant that will contain either the Appethyl™ or placebo. Participants will be given a lunch of about 750 calories and 40% fat prepared by the Metabolic Kitchen and be asked to eat all of it. Participants will have food choice testing performed 4 hours after starting their lunch meal. This will be done in two ways. Participants will be given a list of two foods that are made of carbohydrate like bread and pretzels and be asked which is most preferred. Participants will also be given a list of foods that differ in the amounts of fat, carbohydrate and protein that they contain and will be asked to mark the ones that appeal to them.
Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You are a male or female aged 18 to 65 years.
- •You have a BMI (a number calculated from your height and weight) between 25-35 kg/m2, inclusive.
- •Your waist circumference is over 35 inches.
排除标准
- •You have been on a diet for weight loss in the last 2 months.
- •You are being treated for blood pressure, diabetes, heart disease, rheumatoid arthritis, or blood vessel disease.
- •You have a psychotic illness.
- •You have other chronic diseases like an inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- •You have a dysfunction of your gastrointestinal tract.
- •You have food allergies.
- •You have rheumatoid arthritis with inflammation.
- •You have chronic constipation.
- •You are taking any products to lose weight such as medication for obesity or non-prescription medications for weight loss.
研究组 & 干预措施
Appethyl™, then Placebo
Participants receive Appethyl™ liquid once four hours after breakfast. After a washout period of at least one week, they received the placebo drink once four hours after breakfast.
干预措施: Placebo (Other)
Appethyl™, then Placebo
Participants receive Appethyl™ liquid once four hours after breakfast. After a washout period of at least one week, they received the placebo drink once four hours after breakfast.
干预措施: Appethyl™ (Dietary Supplement)
Placebo, then Appethyl™
Participants receive the placebo drink once four hours after breakfast. After a washout period of at least one week, they received Appethyl™ liquid once four hours after breakfast.
干预措施: Appethyl™ (Dietary Supplement)
Placebo, then Appethyl™
Participants receive the placebo drink once four hours after breakfast. After a washout period of at least one week, they received Appethyl™ liquid once four hours after breakfast.
干预措施: Placebo (Other)
结局指标
主要结局
Difference in Pizza Consumed During Two Meals
时间窗: 5 hours after lunch (9 hours after administration of Appethyl from the morning)
Four hours after breakfast administration of Appethyl™ or placebo(inactive liquid) is given. You will be presented with a standard lunch and then (5 hours after lunch) pizza in a quantity of more than you could reasonably be expected to eat 5 hours after the start of your lunch meal and be asked to eat to your satisfaction over 30 minutes. You are not expected to eat all of the pizza.
次要结局
- Evaluation of Appetite(30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo)
- Evaluation of Satiety by Means of Visual Analogue Scale(30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo)
研究者
Frank Greenway
Clinical Medical Doctor
Pennington Biomedical Research Center