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New treatment option for Brain Vascular Function
Official title Effects of Protein Supplementation on Brain Function
ClinicalTrials.gov ID: NCT07057245
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Intolerant to milk products or fava bean allergy
- Vegetarians
- Left-handedness
- Current smoker, or smoking cessation \< 12 months
- Diabetic patients
- Familial hypercholesterolemia
See the full eligibility criteria
- 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
- Intolerant to milk products or fava bean allergy
- Vegetarians
- Left-handedness
- Current smoker, or smoking cessation \< 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- 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
- Use medication to treat blood pressure, lipid, or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- 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...
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
The study team makes the final eligibility decision.
Where it's taking place
- Maastricht, Limburg, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maastricht, Limburg, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.