Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cosun | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based protein | Experimental |
| |
| Animal-based protein | Experimental |
| |
| Control arm | Other | Cornstarch providing no extra protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein supplementation with an animal-based protein isolate | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) | Measured after 2 weeks of supplementation with protein isolate or control |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance | Cognitive performance will be assessed with a neuropsychological test battery | Measured after 2 weeks of supplementation with protein isolate or control |
| Appetite-related brain reward activity |
| Measure | Description | Time Frame |
|---|---|---|
| Transcranial Doppler ultrasound | Blood flow velocity in the MCA | Measured after 2 weeks of supplementation with protein isolate or control |
| Blood pressure | Office BP (SBP and DBP) measured in mmHg |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Recruiting | Maastricht | Limburg | 6229ER | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Protein supplementation with a plant-based protein isolate | Dietary Supplement | 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) |
|
| Control arm - cornstarch | Other | 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) |
|
Blood oxygenation level-dependent (BOLD)-functional MRI (fMRI) response to food cues
| Measured after 2 weeks of supplementation with protein isolate or control |
| Measured at baseline and after two weeks of supplementation with protein isolate or control |
| Heart rate | Heart rate (HR) measured in beats/min | Measured at baseline and after two weeks of supplementation with protein isolate or control |
| Metabolic risk markers - Fasting lipids | Fasting lipids:
| Measured at baseline and after two weeks of supplementation with protein isolate or control |
| Metabolic risk markers - glucose and insulin | Fasting glucose and insulin:
| Measured at baseline and after two weeks of supplementation with protein isolate or control |
| Metabolic risk markers - Low-grade systemic inflammation and microvascular function | Low-grade systemic inflammation and microvascular function:
| Measured at baseline and after two weeks of supplementation with protein isolate or control |
| Single nucleotide polymorphisms (SNPs) | Leucocytes will be isolated from EDTA blood. DNA will be isolated from these leucocytes according to standard procedures. DNA will be used for analyzing the presence of known SNPs in genes encoding proteins known to play a role in cholesterol metabolism. | Measured once during the start of the study |
| Perceived hunger and satiety | Visual analogue scale (VAS) questionnaires will be used to assess perceived feelings of hunger, fullness, desire to eat, and prospective food consumption. | Measured after 2 weeks of supplementation with protein isolate or control |
| Anthropometric measurements | At all test days, anthropometric measurements (weight, length, waist and hip circumferences as indirect measures of fat distribution, and skinfold measurements) will be measured | Measured at baseline and after two weeks of supplementation with protein isolate or control |
| Dietary intake | At the end of both interventions, food intake will be measured using a validated food frequency questionnaire (FFQ) | Measured after 2 weeks of supplementation with protein isolate or control |