The Effect of Whole Grain on Gut Microbiome and Metabolic Health

Metabolic Disease Clinical Trial

— 3G  

Official title:

Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01731366
• Other study ID #: M206
• 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)

Related Conditions & MeSH terms

• Injury of Gastrointestinal Tract
• Metabolic Disease
• Metabolic Diseases

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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