Health TrialsbyHealthPanel

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

ConditionGastric Emptying
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Nutren Fresh

    Dietary supplement

    In this intervention, participants will receive 200 ml of the nutritional formula.

  • Maltodextrin (Placebo)

    Dietary supplement

    In this intervention, participants will receive 200 ml of maltodextrin.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: FormulaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gastric Emptying

Gastric emptying will be assessed through scintigraphic imaging obtained immediately after formula consumption and every hour for three hours.

Time frame
On day 1 and day 2 of the protocol.

Secondary outcomes

1

Gastrointestinal symptoms and sensations of hungry, saciety and desire to eat

Use of numerical visual analog scales (from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.), where the volunteer will indicate the presence and intensity of gastrointestinal symptoms (heartburn, nausea, burning sensation, etc.) and sensations of hunger, satiety, and desire to eat.

Time frame
Immediately after formula ingestion, and at 60, 120, and 180 minutes post-ingestion.
2

Blood glucose

To assess capillary blood glucose using a portable glucometer.

Time frame
This assessment will be conducted with the patient in a fasting state, immediately after formula ingestion, and at 60, 120, and 180 minutes post-ingestion on each protocol day.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal University of Minas Gerais

Lead sponsor

Nestle Health Science

Collaborator

Source ClinicalTrials.gov
Apply now