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Improving resilience with whole grain wheat

Completed
Conditions
algehele en metabole gezondheid
fatty liver
glucose metabolism
vascular health
Registration Number
NL-OMON42136
Lead Sponsor
Wageningen Universiteit
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following inclusion criteria:
Males or postmenopausal females (target 50: 50 for both genders)
For females: menstrual cycle absent for more than 1 year
Age 45-70yrs
BMI between 25 and 35 kg/m2
Signed informed consent
Normal food habit of bread and cereal consumption

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Not having a general practitioner
• Having a history of medical or surgical events that may affect the study outcome
• Smoker
• Use of cholesterol lowering medication
• Mental status that is not compatible with proper conduct of the study
• Aversion, intolerance to gluten, whole wheat or other items in the intervention products
• Alcohol consumption of > 21 glasses a week
• Abuse of drugs
• Recent use of antibiotics (<1 month prior to day 01 of the study)
• Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening
• Reported slimming or medically prescribed diet
• Reported vegan or macrobiotic life-style
• Not willing to give up blood donation during the study
• Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
• Current participation in other research
• Contraindication for MRI
• Having blood vessels that make it difficult for inserting a cannula

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter is cardiovascular/ cardio-metabolic health Blood<br /><br>markers include cholesterol, triglycerides, glucose, insulin, lipid profiles,<br /><br>glucagon, oxidized LDL, C-peptide, GIP, GLP-1, HbA1c, plasma adhesion molecules<br /><br>and markers of inflammation. Flow-mediated dilatation (FMD), blood pressure,<br /><br>Pulse Wave Analysis (PWA) and white blood cell count and activation.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary study parameters include liverfat, abdominal fat distrubution, liver-<br /><br>and adipose tissue health,mood questionnaires and do-it-yourself (DIY) devices<br /><br>in quantifying health effects in a nutritional intervention study.</p><br>
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