Effects of Protein Supplementation on Brain Function
NCT07057245 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-07-09
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
- 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)
Sponsors & Collaborators
-
Cosun
collaborator UNKNOWN -
Maastricht University Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 60 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-02
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Netherlands
Study Locations
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