NWT-03 and Brain Function

NCT04831203 | Completed

• 1 other identifier: METC 20-092
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebral Blood Flow; Cognitive Performance

Outcome Measures

Primary Outcomes (2)

• Brain Vascular Function

  Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Cognitive performance

  Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

Secondary Outcomes (6)

• Glucose metabolism

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Peripheral vascular function (1)

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Peripheral vascular function (2)

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Peripheral vascular function (3)

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Peripheral vascular function (4)

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

Other Outcomes (19)

• Systolic and Diastolic Blood pressure

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Advanced glycation endproducts

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

• Blood lipids

  Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period

Study Arms (2)

Protein-hydrolysate

EXPERIMENTAL

Dietary supplement: an egg-protein hydrolysate (NWT-03) Study volunteers will receive a daily powder of 5 g of protein hydrolysate to mix with 200 mL of water for 36 weeks.

Dietary Supplement: An egg-protein hydrolysate (NWT-03)

Control

PLACEBO COMPARATOR

Control: 5 g of maltodextrin powder mixed with 250 mL of water for 36 weeks.

Dietary Supplement: Placebo

Interventions

An egg-protein hydrolysate (NWT-03) DIETARY_SUPPLEMENT

As described in the experimental arm

Protein-hydrolysate

Placebo DIETARY_SUPPLEMENT

As described in the Control arm

Control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged between 60-75 years
• Subjective cognitive decline (SCD)
• BMI between 25-35 kg/m2
• Fasting plasma glucose \< 7.0 mmol/L
• Fasting serum total cholesterol \< 8.0 mmol/L (further testing will be performed for excessive hyperlipidemia \[serum total cholesterol ≥ 8.0 mmol/L\] according to the Standard for cardiovascular risk management of NHG)
• 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

You may not qualify if:

• Left-handedness
• Current smoker, or smoking cessation \< 12 months
• Diabetic patients
• Familial hypercholesterolemia
• Abuse of drugs
• More than 3 alcoholic units per day
• Use of vitamin or mineral supplements known to interfere with the main outcomes as judged by the principal investigators within the previous 1-month
• Use of medication to treat blood pressure, lipid or glucose metabolism
• Use of an investigational product within another 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 diseases and rheumatoid arthritis
• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6211 LK, Netherlands

Location

Related Publications (1)

• Adams MS, Mensink RP, Plat J, Winkens B, Joris PJ. Long-term egg-protein hydrolysate consumption improves endothelial function: a randomized, double-blind, placebo-controlled trial in older adults with overweight or obesity. Eur J Nutr. 2024 Dec 24;64(1):54. doi: 10.1007/s00394-024-03566-w.

  PMID: 39718599 DERIVED

MeSH Terms

Interventions

NWT-03

Study Officials

• Peter J Joris, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 23, 2021
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-08

Locations

NL (1)