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Recruiting NCT07296692

NCT07296692 Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals

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Clinical Trial Summary
NCT ID NCT07296692
Status Recruiting
Phase
Sponsor Federal University of Minas Gerais
Condition Gastric Emptying
Study Type INTERVENTIONAL
Enrollment 25 participants
Start Date 2026-02-21
Primary Completion 2027-05

Eligibility & Interventions

Sex All sexes
Min Age 60 Years
Max Age 90 Years
Study Type INTERVENTIONAL
Interventions
Nutren FreshMaltodextrin (Placebo)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 25 participants in total. It began in 2026-02-21 with a primary completion date of 2027-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Simone de Vasconcelos Generoso Generoso, Phd

✉ simonenutufmg@gmail.com

📞 55(031) 988128650

Principal Investigator

Simone de Vasconcelos Generoso Generoso, Phd

PRINCIPAL INVESTIGATOR

Department of Nutrition, Federal University of Minas Gerais

Frequently Asked Questions

Who can join the NCT07296692 clinical trial?

This trial is open to participants of all sexes, aged 60 Years or older, up to 90 Years, studying Gastric Emptying. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07296692 currently recruiting?

Yes, NCT07296692 is actively recruiting participants. Contact the research team at simonenutufmg@gmail.com for enrollment information.

Where is the NCT07296692 trial being conducted?

This trial is being conducted at Belo Horizonte, Brazil.

Who is sponsoring the NCT07296692 clinical trial?

NCT07296692 is sponsored by Federal University of Minas Gerais. The principal investigator is Simone de Vasconcelos Generoso Generoso, Phd at Department of Nutrition, Federal University of Minas Gerais. The trial plans to enroll 25 participants.

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