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Improving resilience with whole grain wheat

Improving resilience with whole grain wheat - graandioos

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42136
Enrollment
50
Registered
2015-01-21
Start date
2015-03-18
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

algehele en metabole gezondheid fatty liver glucose metabolism vascular health

Interventions

A twelve week intervention of either 98g whole grain wheat (WGW) or a control intervention of refined wheat (RW) in the form of 4 slices of bread and 2 servings of ready to eat cereals (RTEC).

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 ( 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

Design outcomes

Primary

MeasureTime frame
The main study parameter is cardiovascular/ cardio-metabolic health Blood markers include cholesterol, triglycerides, glucose, insulin, lipid profiles, glucagon, oxidized LDL, C-peptide, GIP, GLP-1, HbA1c, plasma adhesion molecules and markers of inflammation. Flow-mediated dilatation (FMD), blood pressure, Pulse Wave Analysis (PWA) and white blood cell count and activation.

Secondary

MeasureTime frame
Secondary study parameters include liverfat, abdominal fat distrubution, liver- and adipose tissue health,mood questionnaires and do-it-yourself (DIY) devices in quantifying health effects in a nutritional intervention study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)