The Effect of Fatty Acid Composition on Energy Intake and Satiety (NCT00242021) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Fatty Acid Composition on Energy Intake and Satiety
Netherlands20 participantsStarted 2005-10
Plain-language summary
The objective of the study is to investigate the effect of fatty acid composition of a fat supplement:
1. acutely (after single intake) on subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes;
2. in the long-term (after one week) on (regulators of) fat tissue metabolism.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
. Males aged between 18 - 60 years at Day 01 of the study;
. Normal weight subjects and overweight/obese subjects, Body Mass Index (BMI) will be at least two units different between the heaviest normal weight and the lightest overweight subject, the largest contrast between groups will be aimed at, e.g normal weight BMI between 18 and 25 kg/m2 and overweight/obese BMI between 27.5-35 kg/m2;
. Regular Dutch eating habits as assessed by P6468 F02 and used to breakfast consumption;
. Non restrained eater, defined as a score of \< 2.5 in lean and \<3.25 in obese men on the Dutch Eating Behaviour Questionnaire;
. Appropriate veins for blood sampling/cannula insertion according to TNO;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes
. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
. 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;
. Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or hypertension;
. Use of medication that may influence appetite, and/or sensory functioning within 14 days before day 01, except paracetamol;
. Allergic reaction to chlorhexidine and/or lidocaine (anaesthetic solution);
. Having a history of or current alcohol consumption of more than 28 units/week;
. Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening;
. Mental or physical status that is incompatible with the proper conduct of the study;