RecruitingNot ApplicableNCT07296692

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

Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals: a Randomized, Crossover, Triple-blind Clinical Trial.


Sponsor

Federal University of Minas Gerais

Enrollment

25 participants

Start Date

Feb 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 90 Years

Inclusion Criteria12

  • 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
  • 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

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Interventions

DIETARY_SUPPLEMENTNutren Fresh

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

DIETARY_SUPPLEMENTMaltodextrin (Placebo)

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


Locations(1)

School of Nursing, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

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NCT07296692


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