Objective: The objective of the study is to evaluate the digestive tolerance of three dosages of a sugar replacing product consumed daily for two weeks versus a reference
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
uiteindelijk doel preventie van overgewicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Not applicable
Background summary
Rationale: Daily sugar intake has dramatically increased over the past decades
(> 30%) and is directly associated with obesitas and health complaints. To
decrease obesitas replacement of sugar with a product having a comparable
sweetness but a much lower caloric value is a good alternative. In this study
the tolerance of a low caloric sugar replacing product is investigated in human
volunteers. The tolerance of this product in 3 different daily doses consumed
for a period of 2 weeks will be evaluated versus a reference. The tolerance
will be evaluated using questionnaires related to GI complaints.
Study objective
Objective: The objective of the study is to evaluate the digestive tolerance of
three dosages of a sugar replacing product consumed daily for two weeks versus
a reference
Study design
Study design: Randomized (BMI and age; gender in design), reference-controlled,
double-blind, 4-way cross over design
Intervention
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 product X (70 g/d)
- Treatment 4: reference (table top sugar) (40 g/d)
All treatments will be supplied to the subjects in processed foods (e.g., cake)
Subjects will consume the study products daily at home for a period of 2 weeks.
Evaluation of the GI complaints will be performed using a questionnaire
directly following the 2 weeks of consumption. Subjects will keep a diary, in
which they register the daily consumption of the study products, the frequency
and appearance of defecations and any other remarks or complaints.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Consumption of sugar within the general
population is irrespective of age and a daily habit. The selected number of
subjects in this study is 1) based on experience with previous studies
performed at TNO and 2) to detect a change in response of 1 category in
flatulence between treatments. Based on 1) the fact that all individual
ingredients are on the market for a long time and that each is numbered and
listed or affirmed as GRAS (Generally Recognized as Safe) by the FDA and 2) the
limited duration of consumption of the product (2 weeks) it is highly unlikely
to expect any serious complaint due to the treatments. Only very minor or
negligible effects such as increased flatulence are expected to occur.
Therefore, the risks for subjects participating in the study are negligible and
the body burden is minimal.
Boomsesteenweg 945
2610 Antwerpen
Belgie
Boomsesteenweg 945
2610 Antwerpen
Belgie
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19052.028.07 |