CompletedNot Applicable

Digestion of Biopolymer Based Lipid Emulsions

Switzerland21 participantsStarted 2016-03

Plain-language summary

In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that they differ in terms of acid stability, lipid droplet size and fat redispersibility. The investigators hypothesize that the gastric emptying of fat will differ between the lipid emulsions. An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded study.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

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: * BMI 18-25 kg/m² * Written informed consent Exclusion Criteria: * Donated blood within the last 3 months * History of GI, cardiorespiratory (including arterial * hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes * Prior abdominal surgery other than uncomplicated appendectomy or hernia repair * Requiring medication that might alter gut function, including calcium channel blockers, prokinetics, macrolide antibiotics * Presence of metallic implants, devices or metallic foreign bodies * Pregnancy and lactation (female participants of child bearing age will receive a pregnancy test prior to study) * Claustrophobia * Regular smoking * A history of drug or alcohol abuse * A history of food allergies or intolerances * Uncertainty about the willingness or ability of the participant to comply with the protocol requirements

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

The rate of gastric fat volume emptying [ml/h]

Timeframe: up to 210 min

Trial details

NCT IDNCT02865486

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

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