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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01731366
Other study ID # M206
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 15, 2012
Last updated September 1, 2014
Start date August 2012
Est. completion date December 2015

Study information

Verified date September 2014
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health .

Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included.

Intervention: low vs. high whole grain intake.


Description:

The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a diet rich in whole grain in the active treatment period and a refined grain diet during the control period.

Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2015
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Body mass index (BMI): 25 - 35 kg/m2

- No medical prescribed diet

- Weight stable

- No blood donation during the study

- Intense sporting activities less than 10h/ week

- Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)

- Signed written consent

Exclusion Criteria:

- Pharmacological treatment; hypertension, diabetes and blood lipid regulation

- Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study

- Participation in another biomedical trial 1 month prior to study start

- Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis

- Reported chronic gastrointestinal disorders

- Antibiotic treatment for 3 month prior to study start

- Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start

- Blood hemoglobin < 7.0 mmol/l

- Blood donation within 1 month prior to study start

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)


Intervention

Other:
Whole grain
Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)
Refined grain
Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Locations

Country Name City State
Denmark Department of Human Nutrition, University of Copenhagen Fredriksberg

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other 4-days precoded food diary Assessment of dietary intake via food frequency questionnaire as a measure of compliance December 2014 No
Other n-3 fatty acid status Assessed as DHA percentage in a whole blood fatty acid analysis. Included as a potential effect modificator in relation to immune function and metabolic outcomes. At the end of the intervention periods No
Other Alkyresorcinol Measured in plasma as a marker of compliance to the whole grain intervention. At the end of the intervention periods No
Primary HOMA-IR Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5) At the end of the intervention periods No
Primary Metagenomic profile Altered quantitative metagenomics at bacterial gene- and species levels, which is a non-specific outcome, but included as the main hypothesis of the project is to test if HOMA-IR is affected via changes in the gut microbiome. At the end of the intervention periods No
Secondary Mean intestinal transit time Participants are instructed in swallowing capsules containing different small non-invasive and non-absorbable plastic pellets for 6 consecutive days. On the seventh day they are having an X-ray of the abdomen taken. At the end of the intervention periods No
Secondary Gastrointestinal permeability, Lactulose/ mannitol ratio 5 hours urine collection following intake of lactulose and mannitol At the end of the intervention periods No
Secondary Colonic fermentation Measurement of breath hydrogen excretion (at before and 30, 60, 90, 120, 150, 180 after intake of standard breakfast) and plasma short-chain fatty acids (fasting and 30, 60, 120, 180 minutes after standard breakfast) At the end of the intervention periods No
Secondary Saliva microbial flora Determination of fasting microbial composition of flora. At the end of the intervention periods No
Secondary Blood pressure Measurement of supine systolic and diastolic blood pressure (3 times) At the end of the intervention periods No
Secondary Appetite hormones Determination of different appetite hormones in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast) At the end of the intervention periods No
Secondary Blood lipid profile Measurement of different blood lipids in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast) At the end of the interventions periods No
Secondary Body composition Measurement of body fat mass and percentage via bio-impedance At the end of the intervention periods No
Secondary Subjective appetite sensation Assessment of subjective appetite sensation via visual analogue scales At the end of the intervention periods No
Secondary Energy intake Assessment of energy intake at an ad libitum meal 3 hours after a standard breakfast At the end of the intervention periods No
Secondary Ex vivo cytokine production Production of cytokines (such as IL-1beta, IL-6) in stimulated whole blood cultures. At the end of the intervention periods No
Secondary Gene expression Assessed by mRNA qPCR in whole blood and cells from whole blood stimulation. Main focus is put on genes involved in immune function and metabolic regulation. At the end of the intervention periods No
Secondary Immune cell profiling Assessed by flow cytometry of whole blood. At the end of the intervention periods No
Secondary Immune markers Fasting plasma cytokines, hsCRP, and LPS/LPS-BP At the end of the intervention periods No
Secondary Blood immune cell content Assessed by hematological cell counts At the end of the intervention periods No
Secondary Markers og glucose hemostasis Measurement of plasma concentrations of Insulin, Proinsulin and HbA1c At the end of the intervention periods No
Secondary Markers of one-carbon metabolism Assessed by plasma homocystein, SAM/SAH and betain At the end of the intervention periods No
Secondary Plasma adipokines Leptin and adiponectin December 2015 No
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