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临床试验/NCT02396615
NCT02396615已完成不适用

SATIN WP4 - The Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Ad libitum energy intake

研究概览

简要总结

The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term.

详细描述

A double-blind, randomised crossover design will be employed with an experimental (active) condition and a control condition at least one week apart. After having successfully completed screening procedures eligible participants will be invited for two separate test days, at least 7 days apart. On the two test days, the products will be provided in a randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be measured every 30 min for the following 8 hours. Satiety and satiation will be measured through administration of test meals in the laboratory supplied with controlled food intake under free-living conditions

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who have provided written informed consent
  • Healthy men and women
  • Ages between 18 and 55 years
  • BMI between 25.0-31.9 kg/m2
  • Regular breakfast eaters (eating breakfast ≥ 4 times a week)
  • Regular menstrual periods (women only)

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 (women only)
  • History of anaphylaxis to food
  • Any known food allergies or food intolerance
  • 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 (women only)

结局指标

主要结局

Ad libitum energy intake

时间窗: Test day 2 (week 1)

Total ad libitum energy intake during test day 2

次要结局

  • VAS score for appetite sensation - hunger(Every 30 min during test day 1 and test day 2)
  • Eating behaviour questionnaire - three factor eating questionnaire(screening)
  • VAS score for appetite sensation - prospective consumption(every 30 min during test day 1 and test day 2)
  • Eating behaviour questionnaire - binge eating scale(Screening)
  • Eating behaviour questionnaire - Control of Eating(screening)
  • Eating behaviour questionnaire- power of food(screening)
  • VAS score for appetite sensation - Desire to eat(every 30 min during test day 1 and test day 2)
  • VAS score for appetite sensation - fullness(every 30 min during test day 1 and test day 2)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Mikael Sjödin, MD, PHD ass professor

Dr, PhD, Associate Professor,

University of Copenhagen

研究点 (2)

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