NCT02385149

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

February 19, 2015

Last Update Submit

November 19, 2015

Conditions

HealthyMetabolism

Keywords

resiliencechallenge testwhole grain wheatmetabolic flexibilitycardio-metabolicliver and adipose tissue

Outcome Measures

Primary Outcomes (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

    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)

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

    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)

  • Change in do-it-yourself measure outcomes (composite)

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

  • Change in health and mood questionaire outcomes

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

  • Change in blood markers of whole grain intake

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

Other Outcomes (3)

  • Change in peripheral blood mononuclear cells

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

  • Change in markers of satiety (composite)

    Baseline and after 12 week intervention (at 0 and 12 weeks, during fasting and in response to a mixed meal challenge test (at 10,30,60,120,240 min postprandial)

  • Urine and faecal collection

    Baseline and after 12 week intervention (at 0 and 12 weeks)

Study Arms (2)

whole grain wheat

EXPERIMENTAL

98g whole grain wheat per day for 12 weeks

Other: whole grain wheat

refined wheat

EXPERIMENTAL

coloured refined wheat control intervention

Other: refined wheat

Interventions

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).

whole grain wheat
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).

refined wheat

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen Universiteit Division of Human Nutrition

Wageningen, Gelderland, 6703HD, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 36330140DERIVED

  • 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.

    PMID: 33188417DERIVED

  • 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.

    PMID: 31504709DERIVED

  • 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.

    PMID: 30541093DERIVED

Study Officials

  • Lydia Afman, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 11, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-03

Locations

NL(1)