NCT07296692

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026May 2027

First Submitted

Initial submission to the registry

September 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 21, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

September 26, 2025

Last Update Submit

April 29, 2026

Conditions

Gastric Emptying

Keywords

proteínselderlygastric emptyingscintigraphy

Outcome Measures

Primary Outcomes (1)

  • Gastric Emptying

    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 Outcomes (2)

  • Gastrointestinal symptoms and sensations of hungry, saciety and desire to eat

    Immediately after formula ingestion, and at 60, 120, and 180 minutes post-ingestion.

  • Blood glucose

    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.

Study Arms (2)

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

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.

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Nutren FreshDIETARY_SUPPLEMENT

In this intervention, participants will receive 200 ml of the nutritional formula.

Formula
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

In this intervention, participants will receive 200 ml of maltodextrin.

Placebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Interventions

maltodextrin

Study Officials

  • Simone de Vasconcelos Generoso Generoso, Phd

    Department of Nutrition, Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone de Vasconcelos Generoso Generoso, Phd

CONTACT

55(031) 988128650simonenutufmg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 26, 2025

First Posted

December 22, 2025

Study Start

February 21, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)