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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: t
View:

• Men and women, aged between 60-75 years (older adults)

• BMI between 25-35 kg/m2 (overweight or obese)

• Fasting plasma glucose \< 7.0 mmol/L

• Fasting serum total cholesterol \< 8.0 mmol/L

• Fasting serum triacylglycerol \< 4.5 mmol/L

• Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg

• Stable body weight (weight gain or loss \< 3 kg in the past three months)

• Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study

• No difficult venipuncture as evidenced during the screening visit

Locations
Other Locations
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 25
Treatments
Experimental: Plant-based protein
Experimental: Animal-based protein
Other: Control arm
Cornstarch providing no extra protein
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Cosun

This content was sourced from clinicaltrials.gov