Improving Resilience With Whole Grain Wheat

Healthy Clinical Trial

— Graandioos  

Official title:

Improving Resilience With Whole Grain Wheat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385149
• Other study ID #: NL51389.081.14
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: November 19, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

The inclusion of subjects with mildly impaired cardio-metabolic risk profiles enables detection of improvements in health after WGW consumption. The investigators therefore aim to include 50 middle aged and overweight males or postmenopausal females (45-70yrs and BMI between 25-35 kg/m2) that have mildly elevated levels of cholesterol (cholesterol levels > 5 mmol/L). In case the inclusion of subjects with mildly elevated levels of total cholesterol is too difficult, normal levels of total cholesterol (< 5 mmol/L) can be accepted, but with a minimum total cholesterol level of 4.5 mmol/L.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Metabolism

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Netherlands	Wageningen Universiteit Division of Human Nutrition	Wageningen	Gelderland

Sponsors (6)

Lead Sponsor	Collaborator
Wageningen University	Cereal Partners Worldwide, Goodmills, Nederlands Bakkerij Centrum, TNO, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in peripheral blood mononuclear cells	gene expression	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)	No
Other	Change in markers of satiety (composite)	parameters include questionaires and blood markers of satiety	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)	No
Other	Urine and faecal collection	To determine markers of compliance and microbiota profiling	Baseline and after 12 week intervention (at 0 and 12 weeks)	No
Primary	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)	No
Secondary	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	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)	No
Secondary	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.	At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)	No
Secondary	Change in health and mood questionaire outcomes	health and mood questionaires (some questionaires are every 4weeks)	At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)	No
Secondary	Change in blood markers of whole grain intake	such as alkylresorinol	before and after 12 week intervention (at 0 and 12 weeks)	No