A double-blind, randomized, placebo-controlled, crossover study on the effect of a dietary oil composition on food intake
- Conditions
- food intakesatiety10003018
- Registration Number
- NL-OMON35155
- Lead Sponsor
- DSM Nutritional Products
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the present study is to investigate the effect of the<br /><br>fat emulsion (6 gram and 12 gram) versus placebo on energy intake at lunch</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are to investigate the effect of the fat emulsion (6 gram<br /><br>and 12 gram) versus placebo on:<br /><br>• Energy intake at dinner (MJ)<br /><br>• Energy intake at lunch and dinner (MJ)<br /><br>• Energy intake at the second day (MJ) (self-reported)<br /><br>• Hunger and satiety (self reported)</p><br>