Clinical trial Recruiting at 1 site Interventional Ages 60 to 90

Does adding protein to a carbohydrate drink change stomach emptying in older adults?

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.

Run by Federal University of Minas Gerais · NCT07296692 · Data updated 2026-11-12

This test will see if a drink with both protein and carbohydrates slows stomach emptying or causes stomach symptoms in people aged 60–90.

Quick facts

Study typeInterventional
Ages60 Years to 90 Years
SexAll
Enrollment25 (estimated)
SponsorFederal University of Minas Gerais
Academic / other
Locations1 site (Belo Horizonte, Minas Gerais)
StatusRecruiting
StartedFebruary 21, 2026
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedMay 5, 2026
Trial IDNCT07296692 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are non-smoking adults aged 60–90 who eat orally, have BMI ≤35, and have no medical conditions or medications known to delay gastric emptying.

Probably not a fit

People with known delayed gastric emptying, routine prokinetic use, untreated H. pylori infection, upper gastrointestinal cancers, severe obesity (BMI >35), or cognitive disorders like Alzheimer's or Parkinson's are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, triple-blind, crossover trial compares a protein-plus-carbohydrate formula (Nutren Fresh) with a carbohydrate-only formula (maltodextrin) in adults aged 60–90. Participants fast for eight hours and undergo gastric scintigraphy on two separate days at least seven days apart after consuming the assigned formula, and they report gastrointestinal symptoms using visual analog scales. The protocol also examines administration at two different preoperative timing points to reflect possible shorter fasting strategies. The single-center study is run by the Federal University of Minas Gerais in collaboration with Nestlé Health Science.

Why it matters

Potential benefit: If successful, this could support using protein-containing preoperative drinks to safely shorten fasting and improve nutrition and recovery in older surgical patients.

How similar studies have gone: Carbohydrate-only preoperative drinks are well studied and generally safe, and protein-containing formulas have shown some nutritional benefits but have limited data specifically on gastric emptying in elderly patients.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • School of Nursing, Federal University of Minas Gerais
    Belo Horizonte, Minas Gerais, Brazil
    Recruiting

Study contacts

  • Principal investigator: Simone de Vasconcelos Generoso Generoso, Phd — Department of Nutrition, Federal University of Minas Gerais
  • Study coordinator: Simone de Vasconcelos Generoso Generoso, Phd
  • Email: simonenutufmg@gmail.com
  • Phone: 55(031) 988128650

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.