An egg-protein hydrolysate (NWT-03) to boost brain function - mind your blood vessels

Completed

• Conditions: Insulin Resistance Syndrome; Syndrome X; Metabolic Syndrome; 10018424

• Registration Number: NL-OMON50991
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

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 products or dietary 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are the difference in brain vascular function and<br /><br>cognitive performance between interventions. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are effects on insulin-sensitivity and peripheral vascular<br /><br>function.</p><br>