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A double-blind, randomized, placebo-controlled, crossover study on the effect of a dietary oil composition on food intake

A double-blind, randomized, placebo-controlled, crossover study on the effect of a dietary oil composition on food intake - Effect of a dietary oil composition on food intake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35155
Enrollment
40
Registered
2011-11-14
Start date
2011-12-20
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

food intake satiety

Interventions

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 wa

Sponsors

DSM Nutritional Products
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 =26 kg/m2) DEBQ-restraint score

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)