Digestive tolerance of several doses of a sugar replacing product

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The tolerance of the products will be<br /><br>evaluated by questionnaires filled in directly following a two week period of<br /><br>consumption of each of the products at home. Also the reported GI complaints<br /><br>will be evaluated by the daily filled in diary, in which they register the<br /><br>consumption of the study products, the frequency and appearance of defecations<br /><br>and any other remarks or complaints such as flatulence.</p><br>

Secondary Outcome Measures