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

April 29, 2026 updated by: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preoperative fasting (POF) is defined as the absence of food or fluid intake in the hours preceding surgery. POF is recommended to minimize the risk of aspiration of gastric contents and related complications. However, the incidence of such complications is low. Prolonged fasting can have adverse effects on the patient's health, such as headache, dehydration, hypovolemia, and hypoglycemia, potentially compromising postoperative recovery.

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Simone de Vasconcelos Generoso Generoso, Phd
  • Phone Number: 55(031) 988128650
  • Email: simonenutufmg@gmail.com

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Recruiting
        • School of Nursing, Federal University of Minas Gerais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: Nutren Fresh
In this intervention, participants will receive 200 ml of the nutritional formula.
Placebo Comparator: 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.
Dietary supplement: Maltodextrin (Placebo)
In this intervention, participants will receive 200 ml of maltodextrin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Emptying
Time Frame: On day 1 and day 2 of the protocol.
Gastric emptying will be assessed through scintigraphic imaging obtained immediately after formula consumption and every hour for three hours.
On day 1 and day 2 of the protocol.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms and sensations of hungry, saciety and desire to eat
Time Frame: Immediately after formula ingestion, and at 60, 120, and 180 minutes post-ingestion.
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.
Immediately after formula ingestion, and at 60, 120, and 180 minutes post-ingestion.
Blood glucose
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.
To assess capillary blood glucose using a portable glucometer.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Nestle Health Science

Investigators

  • Principal Investigator: Simone de Vasconcelos Generoso Generoso, Phd, Department of Nutrition, Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91081525.0.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Emptying

Clinical Trials on Nutren Fresh

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe