CompletedNot Applicable

Residual Gastric Volume After the Ingestion of Supplements Containing Carbohydrates and Whey Protein

Brazil6 participantsStarted 2022-04-01

Plain-language summary

Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. This is a randomized crossover study including six healthy young volunteers who were submitted to abdominal MRI in 3 phases: 1) after a overnight fast, 2) after drank 200 mL of an OS containing whey protein and carbohydrates (no lipids), and 3) 3h after ingestion of the mentioned OS. The gastric residual volume (GRV) will be evaluate by MRI. The overall findings would allow us to conclude whether the GRV, assessed by MRI, in healthy young volunteers after three hours of the ingestion of 200 ml of an oral supplement containing carbohydrates associated with whey proteins is similar to the GRV found after an overnight fast. This pilot study will add important information to allow future randomized trials including an arm with patients undergoing elective surgical procedures with a 3h fasting after the ingestion of an OS containing whey protein and carbohydrates.

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

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Inclusion Criteria: * Male * Young * Healthy volunteers Exclusion Criteria: * Gastroparesis * Any gastrointestinal condition, * Any chronic disease, * Alcohol or any drug ingestion the day before of the MRI study * Not completion of the 3 phases of the study protocol

Questions worth asking your doctor

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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?

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Questions for the trial coordinator

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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?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

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What they're measuring

Gastric Residual Volume

Timeframe: 3 hours

Trial details

NCT IDNCT05573854

SponsorFederal University of Mato Grosso

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-30

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