Actively Recruiting
Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals: a Randomized, Crossover, Triple-blind Clinical Trial
Led by Federal University of Minas Gerais · Updated on 2026-05-05
25
Participants Needed
1
Research Sites
N/A
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
This trial evaluates how a nutritional formula made of carbohydrates and proteins affects gastric emptying compared to a formula made only of carbohydrates in elderly individuals aged 60 to 90 years. The study aims to determine if the protein-plus-carbohydrate formula delays stomach emptying and whether it causes any gastrointestinal symptoms. Researchers focus on this because aging can slow gastric emptying and affect surgery fasting guidelines. Participants receive two different formulas on separate days in a randomized, crossover, triple-blind design. One formula contains carbohydrates and proteins, and the other contains only carbohydrates. After drinking the formula, participants undergo scintigraphy imaging immediately and at 60, 120, and 180 minutes to measure how fast their stomach empties. There is a 7-day washout period between treatments. During the study, participants fast for 8 hours before each visit and report any gastrointestinal symptoms and sensations like hunger and fullness using visual scales. Blood glucose is measured multiple times during each visit. The main outcome is gastric emptying time, with secondary measures including symptoms and blood glucose levels. The total involvement includes two study days spaced apart by a week, with detailed monitoring during each session.
CONDITIONS
Brief 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 infection, stomach cancer, or 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/m8)
- 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days with a 7-day washout period between days
Participants receive two different nutritional formulas in a randomized order on separate days, with a 7-day washout period between each administration. Gastric emptying is measured through scintigraphic imaging immediately after ingestion and at 60, 120, and 180 minutes post-ingestion.
2 study visits for formula ingestion and imaging assessments
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
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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