Cognition Clinical Trial
Official title:
An Egg-protein Hydrolysate (NWT-03) to Boost Brain Function - Mind Your Blood Vessels
Verified date | August 2022 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | October 24, 2022 |
Est. primary completion date | October 24, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Systolic and Diastolic Blood pressure | Office and 24-hour ambulatory blood pressure | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Advanced glycation endproducts | Serum protein-bound advanced glycation endproducts (AGEs) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Blood lipids | Lipids and Lipoproteins | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Blood glucose | Glucose | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Blood Insulin | insulin | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Blood markers for low-grade systemic inflammation | Markers for low-grade systemic inflammation (IL-6, TNF-alpha) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Blood markers for microvascular function | Markers for microvascular function (sCAM-1, vWf, cGMP) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Blood marker of neurogenesis | Brain-derived neurotrophic factor | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Structural brain status | MRI Structural MPRAGE scan | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Other perceivable benefits: Quality of Life | The Quality of life will be assessed using a 32-item questionnaire | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Other perceivable benefits: Physical fitness (1) | Timed up-and-go test (TUGT) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Other perceivable benefits: Physical fitness (2) | The 6-minute walk test (6 MWT) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Other perceivable benefits: Physical fitness (4) | Muscle strength test, as measured using the Biodex system | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Weight | Weight in kg | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Height | Height in kg | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Waist circumference | Waist circumference in centimeters | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Hip circumference | Hip circumference in centimeters | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Indirect fat distribution | Measured by skinfold measurements | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Other | Food intake | Food intake will be assessed using the Food Frequency Questionnaire | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Primary | 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 | |
Primary | 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 | Glucose metabolism | Oral Glucose Tolerance Test (OGTT) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Secondary | Peripheral vascular function (1) | Flow-mediated vasodilation (FMD) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Secondary | Peripheral vascular function (2) | Carotid artery reactivity (CAR) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Secondary | Peripheral vascular function (3) | Pulse wave analysis (PWA) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Secondary | Peripheral vascular function (4) | Pulse wave velocity (PWV) | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period | |
Secondary | Peripheral vascular function (5) | Retinal microvascular calibers | Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period |
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