Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2015-01-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
whole grain wheat
98g whole grain wheat per day for 12 weeks
whole grain wheat
A twelve week intervention of 98g whole grain wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
refined wheat
coloured refined wheat control intervention
refined wheat
A twelve week control intervention of refined wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
whole grain wheat
A twelve week intervention of 98g whole grain wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
refined wheat
A twelve week control intervention of refined wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 45-70yrs
* BMI between 25 and 35 kg/m2
* Signed informed consent
* Normal food habit of bread and cereal consumption
Exclusion Criteria
* Having a history of medical or surgical events that may significantly affect the study outcome
* Smoker
* Use of cholesterol lowering medication
* Mental status that is incompatible with the 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 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 (with the exception of NQplus)
* Contraindication for MRI
* Having blood vessels that are too difficult for inserting a cannula
45 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TNO
OTHER
Cereal Partners Worldwide
INDUSTRY
Nederlands Bakkerij Centrum
OTHER
Goodmills
UNKNOWN
University Medical Center Groningen
OTHER
Wageningen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lydia Afman, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wageningen Universiteit Division of Human Nutrition
Wageningen, Gelderland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gijbels A, Schutte S, Esser D, Wopereis S, Gonzales GB, Afman LA. Effects of a 12-week whole-grain or refined wheat intervention on plasma acylcarnitines, bile acids and signaling lipids, and association with liver fat: A post-hoc metabolomics study of a randomized controlled trial. Front Nutr. 2022 Oct 13;9:1026213. doi: 10.3389/fnut.2022.1026213. eCollection 2022.
van Trijp MPH, Schutte S, Esser D, Wopereis S, Hoevenaars FPM, Hooiveld GJEJ, Afman LA. Minor Changes in the Composition and Function of the Gut Microbiota During a 12-Week Whole Grain Wheat or Refined Wheat Intervention Correlate with Liver Fat in Overweight and Obese Adults. J Nutr. 2021 Mar 11;151(3):491-502. doi: 10.1093/jn/nxaa312.
Hoevenaars FPM, Esser D, Schutte S, Priebe MG, Vonk RJ, van den Brink WJ, van der Kamp JW, Stroeve JHM, Afman LA, Wopereis S. Whole Grain Wheat Consumption Affects Postprandial Inflammatory Response in a Randomized Controlled Trial in Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study. J Nutr. 2019 Dec 1;149(12):2133-2144. doi: 10.1093/jn/nxz177.
Schutte S, Esser D, Hoevenaars FPM, Hooiveld GJEJ, Priebe MG, Vonk RJ, Wopereis S, Afman LA. A 12-wk whole-grain wheat intervention protects against hepatic fat: the Graandioos study, a randomized trial in overweight subjects. Am J Clin Nutr. 2018 Dec 1;108(6):1264-1274. doi: 10.1093/ajcn/nqy204.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL51389.081.14
Identifier Type: -
Identifier Source: org_study_id