Effects of Protein Supplementation on Brain Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorMaastricht University Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Intolerant to milk products or fava bean allergy

Vegetarians

Left-handedness

Current smoker, or smoking cessation < 12 months

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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)

  • 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 intervention

    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)

Treatment groups

25 Participants
are divided into 3 treatment groups
Group A: Plant-based proteinExperimental treatment 1 intervention
Group B: Animal-based proteinExperimental treatment 1 intervention
Group C: Control armOther 1 intervention

Trial outcomes

Primary outcomes

1

Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity)

Time frame
Measured after 2 weeks of supplementation with protein isolate or control

Secondary outcomes

1

Cognitive performance

Cognitive performance will be assessed with a neuropsychological test battery

Time frame
Measured after 2 weeks of supplementation with protein isolate or control
2

Appetite-related brain reward activity

Blood oxygenation level-dependent (BOLD)-functional MRI (fMRI) response to food cues

Time frame
Measured after 2 weeks of supplementation with protein isolate or control

Other outcomes

1

Transcranial Doppler ultrasound

Blood flow velocity in the MCA

Time frame
Measured after 2 weeks of supplementation with protein isolate or control
2

Blood pressure

Office BP (SBP and DBP) measured in mmHg

Time frame
Measured at baseline and after two weeks of supplementation with protein isolate or control
3

Heart rate

Heart rate (HR) measured in beats/min

Time frame
Measured at baseline and after two weeks of supplementation with protein isolate or control
4

Metabolic risk markers - Fasting lipids

Fasting lipids: * Fasting serum triacylglycerol (TAG) concentrations in mmol/L will be measured * Fasting serum total cholesterol (TC) and HDL-C in mmol/L will be measured

Time frame
Measured at baseline and after two weeks of supplementation with protein isolate or control

Sponsors and contacts

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