Digestive tolerance of several doses of a sugar replacing product - Digestive tolerance of Sweetwell X

Sweetwell N.V.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•Healthy as assessed by
•* the TNO health and lifestyle questionnaire
•* results of the pre-study laboratory test
•2 Females and males, age * 20 and * 60 years at Day 01 of the study
•3 Body Mass Index (BMI) * 18 - * 32 kg/m2
•4 Having a regular defecation frequency
•5 Regular and normal Dutch eating habits (consuming mostly three main meals including breakfast) and snacks as assessed by the questionnaire on health and lifestyle
•6 Daily user of table top sugar in coffee, tea, yoghurt, etc

•1 Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
•2 Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
•3 Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine disease, especially Diabetes type I or II,
•4 Alcohol consumption > 28 units/week (for men) or > 21 units/week (for women)
•5 Reported food allergy or sensitivity (chocolate, wheat, dairy products, egg, nuts, etc)
•6 Having gastro-intestinal complaints regularly (stomach upsets, diarrhoea, constipation, flatulence, abdominal colic, etc)
•7 Reported unexplained weight loss or weight gain of > 2 kg in the month prior to pre-study screening
•8 Use of antibiotics within 1 month, or laxatives, more then once, within 1 week before day 01 of the study
•9 Reported slimming or medically prescribed diet
•10 Pregnant or lactating or wishing to became pregnant in the period of the study

发起方

Sweetwell N.V.