The primary objective of the present study is to investigate the effect of the fat emulsion on energy intake at lunch.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the present study is to investigate the effect of the
fat emulsion (6 gram and 12 gram) versus placebo on energy intake at lunch
Secondary outcome
Secondary objectives are to investigate the effect of the fat emulsion (6 gram
and 12 gram) versus placebo on:
• Energy intake at dinner (MJ)
• Energy intake at lunch and dinner (MJ)
• Energy intake at the second day (MJ) (self-reported)
• Hunger and satiety (self reported)
Background summary
Overweight and obesity are global problems. Weight loss or prevention of weight
gain can be achieved by reducing energy intake or increasing energy
expenditure. Food ingredients that influence the mechanisms that regulate
satiety may play a role in weight management. One of the ingredients that are
associated with short term reductions of food intake and appetite suppression
is a fat emulsion of dietary oils. It is used as a food ingredient and claimed
to reduce appetite and food intake. The main hypothesis tested is that this
mixture reduces energy intake at lunch.
Study objective
The primary objective of the present study is to investigate the effect of the
fat emulsion on energy intake at lunch.
Study design
The study is designed as a randomized, double-blind, placebo-controlled,
cross-over study.
Total study duration will be 3 weeks. In total 40 subjects will visit TNO 4
times. At 3 visits they will stay in the research facility during ca. 10 hours,
and at the fourth visit they will hand in the food diary of the day following
the 3rd visit.
The first three visits are every week on the same day of the week: day 01, day
08, and day 15.
Intervention
The study comproises three treatments:
* 6 gram vegetable fat emulsion;
* 12 gram vegetable fat emulsion; and
* a placebo.
The vegetable fat emulsion has been studied already in various doses in several
studies,. In the present study the product will be used as powder that needs to
be dissolved in water. The product will be consumed as breakfast in the morning
of each testday, after consumption of 250 g yoghurt.
Study burden and risks
Healthy volunteers will not particularly benefit from participation in this
study. By participation a volunteer will contribute to gaining knowlegde about
efficacy of the testsubstance on energy intake.
Volunteers will be asked to come 3 times a whole day to TNO for intake of the
testsubstance at breakfast. They will also consume lunch and diner at TNO. They
are free to consume as much as they like, and therefore the burden is
considered to be low. They are asked to fill in several questionnaires and
diaries, which demands a certain level of disciplin. However, these are
considered to be at an acceptable level and the financial compensation takes
this into acccount.
Postbus 2676
4002 Basel
CH
Postbus 2676
4002 Basel
CH
Listed location countries
Age
Inclusion criteria
1. Healthy as assessed by the TNO health & lifestyle questionnaire and limited physical examination
2. Male or female, age * 18 and * 30 years at Day 01 of the study
3. Body Mass Index (BMI) * 20 and * 27 kg/m2
4. Normal Dutch eating habits; consuming mostly three main meals per day
5. Non restrained eater, defined as the following scores on cognitive restraint according to the Dutch Eating Behaviour Questionnaire: men with a DEBQ-restraint score of <=2.37; women (BMI <26 kg/m2) DEBQ-restraint score <=3.24; women (BMI >=26 kg/m2) DEBQ-restraint score <=3.41)
6. Voluntary participation
7. Having given their written informed consent
8. Willing to comply with the study procedures
9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
Exclusion criteria
1.Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine disorders, gastro-intestinal disorders, eating behaviour disorders.
2. Any prescribed medication with the exception of incidental use of pain killers and use of (oral) contraceptives
3. Intolerance or allergy to milk products
4. Alcohol consumption > 28 units/week for males or > 21 units/week for females
5. Smoking
6. Coffee consumption of > 8 cups/day
7. Reported unexplained weight loss or weight gain of > 2 kg in the 2 months prior to start of the study
8. Reported slimming or medically prescribed diet
9. Reported vegan, vegetarian or macrobiotic diet
10. Pregnant or lactating or wishing to became pregnant during the study period
11. Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study.
12. Participation in any clinical trial including blood sampling and/or administration of substances during the conduct of this study.
13. Personnel of TNO, location Zeist, their partner and their first and second degree relatives
14. Not having a general practitioner
15. Not willing that one*s physician will be informed about participation in this study
16. Not willing to accept information-transfer concerning information regarding a subject*s health (laboratory results, findings at anamnesis or physical examination and eventual adverse events) to and from a subject*s general practitioner.
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 | NL38612.028.11 |