NCT07057245Recruiting
Effects of Protein Supplementation on Brain Function
Effects of Daily Protein Supplementation on Brain Function in Older Adults With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 2 May 2025
- Start date
- Jul 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Obesity
- NCT number
- NCT07057245
What you commit to
- Study type: Interventional
- Planned participants: 25
- From Jul 2025 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of drugs
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
Other illness
- Intolerant to milk products or fava bean allergy
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
Lab values
- Use medication to treat blood pressure, lipid, or glucose metabolism
Other
- Vegetarians
- Left-handedness
- Current smoker, or smoking cessation \< 12 months
- Diabetic patients
- Familial hypercholesterolemia
- More than 3 alcoholic consumptions per day
- Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
Who the study is looking for
- 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
Age in the registry: 60 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.