uiteindelijk doel preventie van overgewicht obesitas reduction
Conditions
Interventions
Intervention: The following 4 treatments will be used in the study:
- Treatment 1: a low dose of product X (30 g/d):
- Treatment 2: a middle dose of product X (50 g/d)
- Treatment 3: a high dose of
Sponsors
Sweetwell N.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The tolerance of the products will be evaluated by questionnaires filled in directly following a two week period of consumption of each of the products at home. Also the reported GI complaints will be evaluated by the daily filled in diary, in which they register the consumption of the study products, the frequency and appearance of defecations and any other remarks or complaints such as flatulence. | — |
Countries
Netherlands
Outcome results
None listed