Actively Recruiting
Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals
Led by Federal University of Minas Gerais · Updated on 2026-05-05
25
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
F
Federal University of Minas Gerais
Lead Sponsor
N
Nestle Health Science
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
School of Nursing, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Actively Recruiting
Research Team
S
Simone de Vasconcelos Generoso Generoso, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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