Does adding protein to a carbohydrate drink change stomach emptying in older adults?
Effect of a Nutritional Formula Composed of Proteins and Carbohydrates on Gastric Emptying in Elderly Individuals: a Randomized, Crossover, Triple-blind Clinical Trial.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Federal University of Minas Gerais Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Trial ID | NCT07296692 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Belo Horizonte, Minas Gerais
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.