NCT02270047已完成不适用
SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation
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
- 50
- 试验地点
- 2
- 主要终点
- AD libitum energy intake
研究概览
简要总结
A 4 week double blinded parallel design with an intervention condition and a control condition will be employed. After having completed screening procedure and a baseline test day, participants will be randomized to either intervention or control condition. In the following 4 weeks, the participants will have to consume the distributed food product daily before completing another test day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants who have provided written informed consent
- •BMI between 23.0-27.9 kg/m2
- •Regular breakfast eaters (eating breakfast ≥ 4 times a week)
- •Regular menstrual periods
排除标准
- •Significant health problems as judged by the investigator
- •Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
- •Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding
- •History of anaphylaxis to food
- •Any known food allergies or food intolerance, specifically the below listed:
- •Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof;
- •Crustaceans and products thereof;
- •Eggs and products thereof;
- •Fish and products thereof;
- •Peanuts and products thereof;
- •Soybeans and products thereof;
- •Milk and products thereof (including lactose);
- •Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia), and products thereof, except for nuts used for making alcoholic distillates including ethyl alcohol of agricultural origin;
- •Celery and products thereof;
- •Mustard and products thereof;
- •Sesame seeds and products thereof;
- •Sulphur dioxide and sulphites;
- •Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
- •Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- •Significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator
- •Significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator
- •Use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator
- •Participants who work in appetite or feeding related areas
- •Participants not able to comply with the study protocol
- •Post-menopausal
研究组 & 干预措施
A
Active Comparator
Orange nectar with NAXUS fibre, 5g/100mL
干预措施: Orange Nectar with fibre (Dietary Supplement)
B
Placebo Comparator
Orange nectar
干预措施: Orange nectar (Dietary Supplement)
结局指标
主要结局
AD libitum energy intake
时间窗: week0, week 4
次要结局
- VAS score for appetite sensation(Week 0, week 4)
研究者
Anders Mikael Sjödin, MD, PHD ass professor
Associated Professor
University of Copenhagen
研究点 (2)
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