Graandioos: Improving Resilience With Whole Grain Wheat

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT02385149

Collaborator

TNO (Other), Cereal Partners Worldwide (Industry), Nederlands Bakkerij Centrum (Other), Goodmills (Other), University Medical Center Groningen (Other)

Enrollment

Location

Arms

5.9

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Metabolism	Other: whole grain wheat Other: refined wheat	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Improving Resilience With Whole Grain Wheat

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: whole grain wheat 98g whole grain wheat per day for 12 weeks	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).
Experimental: refined wheat coloured refined wheat control intervention	Other: 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).

Arm

Intervention/Treatment

Experimental: whole grain wheat

98g whole grain wheat per day for 12 weeks

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).

Experimental: refined wheat

coloured refined wheat control intervention

Other: 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).

Outcome Measures

Primary Outcome Measures

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

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 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 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 blood markers of whole grain intake [before and after 12 week intervention (at 0 and 12 weeks)]
such as alkylresorinol

Other Outcome Measures

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)]
gene expression
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)]
parameters include questionaires and blood markers of satiety
Urine and faecal collection [Baseline and after 12 week intervention (at 0 and 12 weeks)]
To determine markers of compliance and microbiota profiling

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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