Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals
NCT ID: NCT07296692
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2026-01-31
2027-05-31
Brief Summary
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* 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.
Detailed Description
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Shortening the fasting period with nutrient-containing clear liquids administered up to two hours before surgery has been shown to be a safe and beneficial alternative. Additionally, the use of formulas containing not only carbohydrates but also proteins has been tested in order to promote further benefits, such as attenuation of negative nitrogen balance and improvement in patient prognosis.
Given the increasing life expectancy of the population, the number of surgeries in elderly patients is also growing. This is coupled with the fact that aging is associated with physiological reductions in gastric emptying rate and hydrochloric acid secretion, requiring greater care in determining appropriate POF duration.
In this context, the objective of this study is to compare the gastric emptying (GE) of elderly volunteers after consuming a standard formula containing only carbohydrates with another formula composed of both carbohydrates and proteins, administered at two different time points.
This is a randomized, crossover, triple-blind clinical trial involving elderly individuals. The study will include individuals aged 60 years or older, who are non-smokers and have no prior diagnosis of conditions that affect gastric emptying. Patients will be randomized into group A or B to determine the order of interventions. Each volunteer will receive the designated formula in a randomized and blinded manner on the study day, with the formula containing approximately 1 mCi of 99mTc-sodium phytate.
Immediately after finishing the formula intake, participants will undergo the first scintigraphic imaging (T0). Additional scintigraphic images will be taken at 60, 120, and 180 minutes post-ingestion. The mean time to empty half of the gastric content will be assessed, with values less than 25 minutes considered normal.
Gastrointestinal symptoms, as well as sensations of hunger, satiety, and desire to eat, will also be assessed using visual analog scales (VAS), applied on study days. Capillary blood glucose will be measured using a portable glucometer.
Data will be analyzed using statistical software, and normality will be tested to determine the appropriate statistical tests. P-values ≥ 0.05 will be considered statistically significant.
The sample size will be calculated based on a pilot study involving at least 25 volunteers, since there are no similar prior studies. The parameters from this pilot study may then be used to determine the final sample size.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Formula
In this arm, participants will undergo scintigraphy after consuming the formula composed of carbohydrates and proteins, over a period of 3 hours (immediately after ingestion and 1 to 3 hours post-ingestion). After the first arm, a 7-day washout period will be implemented
Nutren Fresh
In this intervention, participants will receive 200 ml of the nutritional formula.
Placebo
In this arm, participants will undergo scintigraphy after consuming the formula composed only of carbohydrates, over a period of 3 hours (immediately after ingestion and 1 to 3 hours post-ingestion). After the first arm, a 7-day washout period will be implemented.
Maltodextrin (Placebo)
In this intervention, participants will receive 200 ml of maltodextrin.
Interventions
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Nutren Fresh
In this intervention, participants will receive 200 ml of the nutritional formula.
Maltodextrin (Placebo)
In this intervention, participants will receive 200 ml of maltodextrin.
Eligibility Criteria
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Inclusion Criteria
* 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
60 Years
90 Years
ALL
Yes
Sponsors
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Nestle Health Science
INDUSTRY
Federal University of Minas Gerais
OTHER
Responsible Party
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Maria Isabel Toulson Davisson Correia
Phd
Principal Investigators
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Simone de Vasconcelos Generoso Generoso, Phd
Role: PRINCIPAL_INVESTIGATOR
Department of Nutrition, Federal University of Minas Gerais
Locations
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School of Nursing, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Countries
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Central Contacts
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Simone de Vasconcelos Generoso Generoso, Phd
Role: CONTACT
Phone: 55(031) 988128650
Email: [email protected]
Facility Contacts
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Simone de Vasconcelos Generoso, Phd
Role: primary
Other Identifiers
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91081525.0.0000.5149
Identifier Type: -
Identifier Source: org_study_id