About this trial
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.
Eligibility criteria
Qualifiers
Elderly individuals aged between 60 and 90 years
Non-smokers
Gastroesophageal reflux
Gastroparesis
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nutren Fresh
- Maltodextrin (Placebo)
Treatment groups
Sponsors and collaborators
Federal University of Minas Gerais
Lead sponsor
Nestle Health Science
Collaborator