Clinical trial NCT02385149: Improving Resilience With Whole Grain Wheat
Official title: Improving Resilience With Whole Grain Wheat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Metabolism
Keywords: resilience
challenge test
whole grain wheat
metabolic flexibility
cardio-metabolic
liver and adipose tissue
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: TNO
name: Cereal Partners Worldwide
name: Nederlands Bakkerij Centrum
name: Goodmills
name: University Medical Center Groningen
First posted: 2015-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cardio-metabolic health parameters (composite)
timeFrame: 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:
measure: Change in liver-and adipose tissue health parameters (composite)
timeFrame: 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)
measure: Change in do-it-yourself measure outcomes (composite)
timeFrame: At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)
measure: Change in health and mood questionaire outcomes
timeFrame: At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)
measure: Change in blood markers of whole grain intake
timeFrame: before and after 12 week intervention (at 0 and 12 weeks)
Other outcomes:
measure: Change in peripheral blood mononuclear cells
timeFrame: 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)
measure: Change in markers of satiety (composite)
timeFrame: 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)
measure: Urine and faecal collection
timeFrame: Baseline and after 12 week intervention (at 0 and 12 weeks)
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen Universiteit Division of Human Nutrition
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Lydia Afman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.