NCT04831203

NWT-03 and Brain Function

Completed NA Last updated 9 November 2022

What this trial tests

NA trial testing An egg-protein hydrolysate (NWT-03) in Brain Vascular Function in 44 participants. Completed in 24 October 2022.

Timeline

23 April 2021

Primary endpoint
24 October 2022

24 October 2022

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	44
Start date	23 April 2021
Primary completion	24 October 2022
Estimated completion	24 October 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• An egg-protein hydrolysate (NWT-03)
• Placebo

Conditions studied

• Brain Vascular Function — all drugs for Brain Vascular Function →
• Cognition — all drugs for Cognition →

Sponsor

Maastricht University Medical Center

Who can join

Adults 60 to 75, any sex, with Brain Vascular Function or Cognition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Age-related chronic diseases including dementia, type II diabetes mellitus (T2DM) and cardiovascular disease (CVD) become more prevalent and of increasing societal concern. Common denominators of these co-morbidities are insulin-resistance and impaired vascular function. Animal and short-term human studies now suggest that NWT-03 - an egg-protein hydrolysate - improves insulin-sensitivity and peripheral vascular function, which are risk markers for the development of T2DM and CVD. Insulin-resistance is also associated with cognitive decline, while impaired brain vascular function is an important event preceding the development of impaired cognitive performance. The investigators have already shown in a shorter-term trial (12 weeks) beneficial effects of a daily dose of 5.0 g of NWT-03 on cognitive performance. However, underlying mechanisms have not yet been addressed, while the long-term effects remain unknown. Thus, the investigators now hypothesize that NWT-03 beneficially affects cognitive performance and brain vascular function following long-term daily intake.

The primary objectives of this trial are to evaluate in overweight or obese adults (aged 60-75) with subjective cognitive decline (SCD) the effects of a 36-weeks NWT-03 intervention on (1) cognitive performance using a neurophysiological test battery, and (2) cerebral blood flow, as quantified by the current non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Secondary study objectives are to examine effects on insulin-sensitivity and peripheral vascular function.

This intervention study will have a randomized, controlled, parallel design. The total study duration will be 36 weeks. Forty-four older adults (aged 60-75 years) with a Body Mass Index (BMI) between 25-35 kg/m2 (overweight or obese) and subjective cognitive decline (SCD), as assessed with the cognitive failure questionnaire, will participate. These study individuals are known to be at increased risk of cognitive impairment, allowing for improvement by the intervention. During the study, subjects will receive daily (in the morning) 5.0 g NWT-03 or placebo powders for 36 weeks.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current understanding and prospects for targeting neurogenesis in the treatment of cognitive impairment.
   Liu Y, Ding X, Jia S, Gu X. · · 2026 · cited 10× · PMID 39820472 · DOI 10.4103/nrr.nrr-d-24-00802
2. Long-term effects of an egg-protein hydrolysate on cognitive performance and brain vascular function: a double-blind randomized controlled trial in adults with elevated subjective cognitive failures.
   Adams MS, Mensink RP, Plat J, Joris PJ. · · 2024 · cited 4× · PMID 38703228 · DOI 10.1007/s00394-024-03394-y
3. Long-term egg-protein hydrolysate consumption improves endothelial function: a randomized, double-blind, placebo-controlled trial in older adults with overweight or obesity.
   Adams MS, Mensink RP, Plat J, Winkens B, et al · · 2024 · cited 2× · PMID 39718599 · DOI 10.1007/s00394-024-03566-w
4. Oral Egg-Derived Protein and Peptide Supplementation for Health Outcomes in Adults: Systematic Review and Meta-Analysis.
   Gong EJ, Bang CS, Lee JJ, Shin YS. · · 2026 · PMID 41978105 · DOI 10.3390/nu18071054