Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorFederal University of Minas Gerais

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

25 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Federal University of Minas Gerais

Lead sponsor

Nestle Health Science

Collaborator