Improving Resilience With Whole Grain Wheat

Not Applicable

Completed

• Conditions: Metabolism; Healthy
• Interventions: Other: refined wheat; Other: whole grain wheat

• Registration Number: NCT02385149
• Lead Sponsor: Wageningen University

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.

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-19
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-11
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• 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)
• Contraindication for MRI
• Having blood vessels that are too difficult for inserting a cannula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
refined wheat	refined wheat	coloured refined wheat control intervention
whole grain wheat	whole grain wheat	98g whole grain wheat per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in cardio-metabolic 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)	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

Secondary Outcome Measures

Name	Time	Method
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)	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
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)	health and mood questionaires (some questionaires are every 4weeks)
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)	DIY tests are optional and include glucose, cholesterol, blood pressure and a OGTT (only week 8). These tests are performed by the subjects.
Change in blood markers of whole grain intake	before and after 12 week intervention (at 0 and 12 weeks)	such as alkylresorinol

Trial Locations

Locations (1)

Wageningen Universiteit Division of Human Nutrition; 🇳🇱 Wageningen, Gelderland, Netherlands