Actively Recruiting
Effects of Daily Protein Supplementation on Brain Function in Overweight or Obese Older Adults
Led by Maastricht University Medical Center · Updated on 2025-07-09
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
C
Cosun
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how daily protein supplementation affects brain function in overweight or obese older adults aged 60 to 75. The study focuses on comparing the effects of plant-derived and animal-derived proteins on brain insulin-sensitivity and vascular function. The goal is to see if these protein supplements can enhance cognitive performance and help regulate appetite, using advanced brain imaging techniques to measure these effects. Participants will consume protein supplements twice daily for two weeks in a randomized order. The supplements include a plant-based protein isolate (fava bean), an animal-based protein isolate (milk), and a control supplement made of cornstarch without extra protein. Each participant will receive all three interventions in separate periods to compare their effects. During the study, researchers will assess cerebral blood flow responses before and after administering intranasal insulin spray to measure brain vascular function and insulin-sensitivity using MRI. They will also evaluate cognitive performance and brain activity related to appetite. The total involvement includes baseline screening, two-week supplementation periods, and brain scans to track changes, with careful monitoring to ensure safety and adherence to the protocol.
CONDITIONS
Brief Title
Effects of Protein Supplementation on Brain Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged between 60 and 75 years
- Body mass index (BMI) between 25 and 35 kg/m2 (overweight or obese)
- Fasting plasma glucose less than 7.0 mmol/L
- Fasting serum total cholesterol less than 8.0 mmol/L
- Fasting serum triacylglycerol less than 4.5 mmol/L
- Systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 100 mmHg
- Stable body weight with less than 3 kg change in the past three months
- Willing to stop being a blood donor from 8 weeks before until 4 weeks after the study
- No difficult venipuncture during screening visit
You will not qualify if you...
- Allergy to milk products or fava beans
- Vegetarian diet
- Left-handedness
- Current smoker or quit smoking less than 12 months ago
- Diabetes diagnosis
- Familial hypercholesterolemia
- Drug abuse
- More than 3 alcoholic drinks per day
- Use of supplements or products affecting study outcomes
- Use of medication for blood pressure, lipids, or glucose metabolism
- Participation in another biomedical trial within the past month
- Severe medical conditions like epilepsy, asthma, kidney failure, COPD, inflammatory or autoimmune diseases
- Active cardiovascular disease or recent heart attack or stroke
- Contraindications for MRI such as pacemaker, metal implants, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks per supplementation period
Participants consume, in random order, twice daily protein supplements consisting of a plant protein isolate, an animal protein isolate, or a control (cornstarch) during separate 2-week periods.
Multiple visits depending on crossover schedule
Trial Site Locations
Total: 1 location
1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229ER
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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