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HealthyGraandioosNCT02385149

Improving Resilience With Whole Grain Wheat

A study testing whole grain wheat and refined wheat in people with Healthy and Metabolism, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the health benefits of whole grain wheat on cardiovascular/ cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal challenge. Read more about this study

Who is it for?
Ages 45 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Metabolism
What is being tested?
whole grain wheat and refined wheat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNetherlands
Study dates
Jan 2015to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Not having a general practitioner
  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen Universiteit Division of Human Nutrition

    Wageningen, Gelderland, 6703HD

Other trials in Netherlands

About this study

This study investigates the health benefits of whole grain wheat on cardiovascular/ cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal challenge. This study also investigates the health benefits of whole grain wheat (WGW) on liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices in quantifying health effects in a nutritional intervention study.

Read the detailed description

The study is a randomized controlled, double blind, parallel trial. A 4-week run-in period with refined wheat (RW) products will be included prior to the intervention for all subjects. Thereafter, two different treatments will be evaluated e.g. a 12-week intervention with whole grain wheat (WGW) products (98g of WGW per day) and a 12-week control intervention with RW products. Two experimental visits will be planned before and two experimental visits will be planned after the 12-week intervention period. In the first experimental visit the investigators will determine liver fat and abdominal fat distribution by magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI). In the second experimental visit the investigators will comprehensively phenotype the participants which will include the response to a mixed meal challenge test.

Conditions
Healthy, Metabolism
Being tested
whole grain wheat, refined wheat
Keywords
resilience, challenge test, whole grain wheat, metabolic flexibility, cardio-metabolic, liver and adipose tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • whole grain wheatOther

    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 wheatOther

    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).

Study groups in NCT02385149
Study groupRoleWhat they receive
whole grain wheatExperimental98g whole grain wheat per day for 12 weeks
Receives: Other: whole grain wheat
refined wheatExperimentalcoloured refined wheat control intervention
Receives: Other: refined wheat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cardio-metabolic health parameters (composite)

    parameters include change in cholesterol, TAG, glucose, insulin, FMD (Fasting only), pulse wave analysis (Fasting and 120, 240min postprandial), blood pressure(Fasting and 120, 240min postprandial), blood cell activation (Fasting only) and plasma markers of cardio-vascular health

    Measured: Baseline and after 12 week intervention (at 0 and 12 weeks) , during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial)

Secondary outcomes (4)

  1. Change in liver-and adipose tissue health parameters (composite)

    parameters include change in intrahepatic lipid accumulation (by MRS, at -1 and 11 weeks), abdominal body fat distribution (by MRI, at -1 and 11 weeks), adipose tissue gene expression (adipose tissue biopsy, fasting only), blood markers of liver health

    Measured: Baseline and after 12 week intervention (at 0 and 12 weeks), during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial)

  2. Change in do-it-yourself measure outcomes (composite)

    DIY tests are optional and include glucose, cholesterol, blood pressure and a OGTT (only week 8). These tests are performed by the subjects.

    Measured: At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)

  3. Change in health and mood questionaire outcomes

    health and mood questionaires (some questionaires are every 4weeks)

    Measured: At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)

  4. Change in blood markers of whole grain intake

    such as alkylresorinol

    Measured: before and after 12 week intervention (at 0 and 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385149
Sponsor's protocol ID
NL51389.081.14
Acronym
Graandioos
Status last verified
Mar 2015
First submitted
19 Feb 2015
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36330140

  • 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.

    PubMed 33188417

  • 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.

    PubMed 31504709

  • 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.

    PubMed 30541093

Questions about this trial

What is this clinical trial studying?

A study testing whole grain wheat and refined wheat in people with Healthy and Metabolism, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cardio-metabolic health parameters (composite) (time frame: Baseline and after 12 week intervention (at 0 and 12 weeks) , during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385149, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

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Improving Resilience With Whole Grain Wheat | AzTrials