Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Eld… (NCT07296692) | Clinical Trial Compass
RecruitingNot Applicable
Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals
Brazil25 participantsStarted 2026-02-21
Plain-language summary
The objective of this clinical trial is to evaluate the effect of a nutritional formula composed of carbohydrates and proteins on gastric emptying in elderly individuals aged between 60 and 90 years. The main questions this study aims to answer are:
* Does the nutritional formula composed of carbohydrates and proteins delay gastric emptying when compared to a formula composed only of carbohydrates?
* Does the formula composed of carbohydrates and proteins cause gastrointestinal symptoms in the study population?
The researchers will compare both formulas (carbohydrates and proteins vs. carbohydrates only) to answer the main question.
Participants will be required to:
* Attend the Nuclear Medicine Department after an 8-hour fast, on two separate days with a minimum interval of seven days for scintigraphy procedures.
* Consume the offered formula in a randomized and blinded manner.
* Report any gastrointestinal symptoms and complete visual analog scales for sensations such as hunger, satiety, and desire to eat.
Who can participate
Age range
60 Years – 90 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:
* Elderly individuals aged between 60 and 90 years
* Non-smokers
* No prior diagnosis of conditions that affect gastric emptying, such as:
* Gastroesophageal reflux
* Gastroparesis
* Untreated Helicobacter pylori (H. pylori) infection
* Stomach cancer
* Esophageal cancer
Exclusion Criteria:
* Volunteers who do not meet the inclusion criteria
* Refusal to sign the informed consent form (ICF)
* Volunteers with obesity (BMI over 35 kg/m²)
* Volunteers who do not eat orally or have a prior diagnosis of delayed gastric emptying and are on routine use of prokinetic medications
* Individuals diagnosed with Alzheimer's or Parkinson's disease
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.