NWT-03 and Brain Function

Summary

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.

Conditions

• Brain Vascular Function
• Cognition

Interventions

DIETARY_SUPPLEMENT

An egg-protein hydrolysate (NWT-03)

As described in the experimental arm

DIETARY_SUPPLEMENT

Placebo

As described in the Control arm

Sponsors & Collaborators

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Peter J Joris, PhD · Maastricht University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-23

Primary Completion

2022-10-24

Completion

2022-10-24

Countries

• Netherlands

Study Locations