Gastric EmptyingNCT07296692
Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals
A study testing Nutren Fresh in people with Gastric Emptying, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Nutren Fresh
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
School of Nursing, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
Simone de Vasconcelos Generoso, Phd, 55(31) 98812-8650, simonenutufmg@gmail.com
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Gastric Emptying
- Being tested
- Nutren Fresh, Maltodextrin (Placebo)
- Keywords
- proteíns, elderly, gastric emptying, scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutren FreshDietary supplement
In this intervention, participants will receive 200 ml of the nutritional formula.
Maltodextrin (Placebo)Dietary supplement
In this intervention, participants will receive 200 ml of maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Formula | Experimental | 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 Receives: Dietary Supplement: Nutren Fresh |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying
Gastric emptying will be assessed through scintigraphic imaging obtained immediately after formula consumption and every hour for three hours.
Measured: On day 1 and day 2 of the protocol.
Secondary outcomes (2)
Gastrointestinal symptoms and sensations of hungry, saciety and desire to eat
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.
Measured: Immediately after formula ingestion, and at 60, 120, and 180 minutes post-ingestion.
Blood glucose
To assess capillary blood glucose using a portable glucometer.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start21 Feb 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Health Science
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Simone de Vasconcelos Generoso Generoso, Phd, Principal investigator, Department of Nutrition, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296692
- Sponsor's protocol ID
- 91081525.0.0000.5149
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals: a Randomized, Crossover, Triple-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT07296692
- Acronym / sponsor ID
- 91081525.0.0000.5149
- Conditions
- Gastric Emptying
- Keywords
- proteíns, elderly, gastric emptying, scintigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Nestle Health Science
- Study start
- 21 Feb 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula | Experimental | Dietary Supplement: Nutren FreshIn 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 |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin (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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Elderly individuals aged between 60 and 90 years
- Non-smokers
- No prior diagnosis of conditions that affect gastric emptying, such as:
- Gastroesophageal reflux
- Gastroparesis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutren FreshIn this intervention, participants will receive 200 ml of the nutritional formula. | Dietary supplement | Formula |
| Maltodextrin (Placebo)In this intervention, participants will receive 200 ml of maltodextrin. | Dietary supplement | Placebo |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone de Vasconcelos Generoso Generoso, Phd principal investigator
Department of Nutrition, Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutren Fresh in people with Gastric Emptying, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone de Vasconcelos Generoso Generoso, Phd (55(031) 988128650, simonenutufmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Emptying (time frame: On day 1 and day 2 of the protocol.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.