SLIM8 - Acute Effects of DC7-2 on Appetite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Energy intake
研究概览
简要总结
A double-blind, randomized crossover design with four arms including three experimental conditions and placebo will be applied. After having successfully completed screening procedures, eligible participants will be invited to four separate test days. The test days are separated with at least 7 days, however 4 days can be accepted for logistical reasons. During the entire course of the study, participants must remain weight stable and not change their diet or physical activity level. Significant changes in diet, physical activity level (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from screening to completion of the last test day) results in exclusion of that subject.
详细描述
For standardization, participants will be asked avoid excessive alcohol consumption (not above 1 unit and no alcohol at all from 8 pm the night before the test days) and intense physical activity 48 hours prior to the test day. Also, they will be asked to consume a standardized meal at home no later than 8 pm the night before the test days. This meal is prepared and delivered by the department.
Furthermore, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation.
Over the course of the study (from screening (visit 1) to completion of the last test day (visit 5)), participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardization before initiating each test day. Possible in-compliance with the standardization will be judged by the sub-investigator whether to result in rescheduling of the visit or to be recorded as a protocol deviation.
Participants arrive at the study facility in the morning. Compliance with standardization is controlled along with registration of possible adverse events and use of concomitant medications. During the test days, participants are settled together with other participants, but separated at individual tables. During the meals, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other. Visual analogue scales (VAS') will be completed for measurement of fasting subjective appetite levels.
The test products (capsules) will be provided prior to a standardized fixed breakfast, prior to a standardized fixed mid-morning snack and prior to an ad libitum meal. Immediately before and after each episode of capsules and food consumption and at 30 minutes intervals, VAS' will be completed. Energy intake will be calculated from the ad libitum meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men
- •Age between 18 and 65 years
- •BMI between 27-35 kg/m2
排除标准
- •Vegetarians
- •Participants unable to consume or known to get nausea from consuming capsules
- •Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown at screening)
- •Any known food allergies or food intolerance likely to affect the present study
- •Weight change of ±3 kg two months prior to the study
- •Vigorous physical activity more than 5 hours/week
- •Alcohol intake above the recommendations from the Danish Health and Medicines Authority (>14 units/week)
- •Substance abuse
- •Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
- •Use currently or within the previous 3 months of any medication or supplements known to affect appetite or body weight as judged by the investigators
- •Chronic diseases (e.g. cancer, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders) or other relevant health problems as judged by the investigators
- •Simultaneous or within the past month participation in other clinical studies
- •Participant's general condition contraindicates participating in the study, as judged by the investigators or the medical expert
研究组 & 干预措施
DC7-2 alone
Administration of DC7-2, a meat-derived octapeptide.
干预措施: DC7-2 (Dietary Supplement)
DC7-2 + potato protein isolate
Administration of DC7-2, a meat-derived octapeptide, combined with potato protein isolate that protects DC7-2 from degradation in the GI tract.
干预措施: DC7-2 + potato protein isolate (Dietary Supplement)
Potato protein isolate + placebo
Administration of potato protein isolate combined with inactive whey protein as placebo.
干预措施: Potato protein isolate (Dietary Supplement)
Placebo
administration of inactive whey protein
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Energy intake
时间窗: 360 min
Assessment of ad libitum energy intake when exposed to one of the test products
次要结局
- Subjective appetite sensations(Six hours during each test day between test day 1, 2, 3, and 4 (acute effect))
研究者
Arne Astrup
Head of Department, Professor MD DMSc
University of Copenhagen