NCT07057245

Effects of Protein Supplementation on Brain Function

Effects of Daily Protein Supplementation on Brain Function in Older Adults With Overweight or Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Protein-rich foods may improve brain insulin-sensitivity, which is important for cognitive and metabolic health, and may also translate into an improved food intake regulation. It is therefore pertinent to delineate the effects of plant-derived proteins, which are a more sustainable alternative to animal-derived proteins, on brain insulin-sensitivity and related functional benefits. The hypothesis is that daily plant-derived or animal-derived protein supplementation improves brain vascular function and insulin-sensitivity, thereby improving cognitive performance and appetite control in overweight or obese older men and women. The primary objective is to investigate in overweight or obese older adults the effect of daily protein supplementation for two weeks with either a plant-derived protein or an animal-derived protein on vascular function and insulin-sensitivity in the brain, while changes in cognitive performance and appetite-related brain reward activity will also be evaluated (secondary study objectives). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be quantified by the gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).

Conditions

• Brain Vascular Function
• Cognitive Function
• Satiety
• Cerebral Blood Flow
• Brain Insulin Sensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein supplementation with an animal-based protein isolate	Study participants will consume, in random order, twice daily (2 x \~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein)
DIETARY_SUPPLEMENT	Protein supplementation with a plant-based protein isolate	Study participants will consume, in random order, twice daily (2 x \~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein)
OTHER	Control arm - cornstarch	Study participants will consume, in random order, twice daily (2 x \~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein)

Timeline

• Start date: 2025-07-02
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: Netherlands