Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)
Denmark34 participantsStarted 2017-11-13
Plain-language summary
A double-blind, randomized crossover design with four arms including three experimental conditions and placebo will be applied. After having successfully completed screening procedures, eligible participants will be invited to four separate test days. The test days cannot be within the same week, however there is no upper limit for days in between, as long as the participants remain weight stable and do not change diet or physical activity level. Significant changes in diet, physical activity level (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from screening to completion of the last test day) results in exclusion of that subject.
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:
* Participants who have provided written informed consent
* Healthy men
* Age between 18 and 60 years
* BMI between 18.5-32 kg/m2
* Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Exclusion Criteria:
* Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of capsules)
* Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown at screening)
* Any known food allergies or food intolerance likely to affect the present study
* Significant health problems as judged by the principal investigator
* Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the study professional
* Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) \< 4 weeks before study start
* Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) during the study
* Use of systemic medical treatment likely to interfere with evaluation of the study parameters as judged by the principal investigator
* Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
* Self-reporting currently dieting or having lost/gained signifi…
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.