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The Effect of Whole Grain on Gut Microbiome and Metabolic Health (3G)

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ClinicalTrials.gov Identifier: NCT01731366
Recruitment Status : Unknown
Verified September 2014 by Arne Astrup, University of Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

November 15, 2012
November 21, 2012
September 3, 2014
August 2012
February 2014   (Final data collection date for primary outcome measure)
  • HOMA-IR [ Time Frame: At the end of the intervention periods ]
    Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
  • Metagenomic profile [ Time Frame: At the end of the intervention periods ]
    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.
  • HOMA-IR [ Time Frame: December 2014 ]
    Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
  • Metagenomic profile [ Time Frame: 2016 ]
    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.
Complete list of historical versions of study NCT01731366 on ClinicalTrials.gov Archive Site
  • Mean intestinal transit time [ Time Frame: At the end of the intervention periods ]
    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.
  • Gastrointestinal permeability, Lactulose/ mannitol ratio [ Time Frame: At the end of the intervention periods ]
    5 hours urine collection following intake of lactulose and mannitol
  • Colonic fermentation [ Time Frame: At the end of the intervention periods ]
    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)
  • Saliva microbial flora [ Time Frame: At the end of the intervention periods ]
    Determination of fasting microbial composition of flora.
  • Blood pressure [ Time Frame: At the end of the intervention periods ]
    Measurement of supine systolic and diastolic blood pressure (3 times)
  • Appetite hormones [ Time Frame: At the end of the intervention periods ]
    Determination of different appetite hormones in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast)
  • Blood lipid profile [ Time Frame: At the end of the interventions periods ]
    Measurement of different blood lipids in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast)
  • Body composition [ Time Frame: At the end of the intervention periods ]
    Measurement of body fat mass and percentage via bio-impedance
  • Subjective appetite sensation [ Time Frame: At the end of the intervention periods ]
    Assessment of subjective appetite sensation via visual analogue scales
  • Energy intake [ Time Frame: At the end of the intervention periods ]
    Assessment of energy intake at an ad libitum meal 3 hours after a standard breakfast
  • Ex vivo cytokine production [ Time Frame: At the end of the intervention periods ]
    Production of cytokines (such as IL-1beta, IL-6) in stimulated whole blood cultures.
  • Gene expression [ Time Frame: At the end of the intervention periods ]
    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.
  • Immune cell profiling [ Time Frame: At the end of the intervention periods ]
    Assessed by flow cytometry of whole blood.
  • Immune markers [ Time Frame: At the end of the intervention periods ]
    Fasting plasma cytokines, hsCRP, and LPS/LPS-BP
  • Blood immune cell content [ Time Frame: At the end of the intervention periods ]
    Assessed by hematological cell counts
  • Markers og glucose hemostasis [ Time Frame: At the end of the intervention periods ]
    Measurement of plasma concentrations of Insulin, Proinsulin and HbA1c
  • Markers of one-carbon metabolism [ Time Frame: At the end of the intervention periods ]
    Assessed by plasma homocystein, SAM/SAH and betain
  • Plasma adipokines [ Time Frame: December 2015 ]
    Leptin and adiponectin
  • Mean intestinal transit time [ Time Frame: December 2014 ]
    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.
  • Gastrointestinal permeability, Lactulose/ mannitol ratio [ Time Frame: December 2014 ]
    5 hours urine collection following intake of lactulose and mannitol
  • Colonic fermentation [ Time Frame: December 2014 ]
    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)
  • Saliva microbial flora [ Time Frame: December 2014 ]
    Determination of fasting microbial composition of flora.
  • Blood pressure [ Time Frame: December 2014 ]
    Measurement of supine systolic and diastolic blood pressure (3 times)
  • Nasal fluid [ Time Frame: December 2015 ]
  • Appetite hormones [ Time Frame: December 2014 ]
    Determination of different appetite hormones in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast)
  • Blood lipid profile [ Time Frame: December 2014 ]
    Measurement of different blood lipids in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast)
  • Body composition [ Time Frame: December 2014 ]
    Measurement of body fat mass and percentage via bio-impedance
  • Subjective appetite sensation [ Time Frame: December 2014 ]
    Assessment of subjective appetite sensation via visual analogue scales
  • Energy intake [ Time Frame: December 2014 ]
    Assessment of energy intake at an ad libitum meal 3 hours after a standard breakfast
  • Ex vivo cytokine production [ Time Frame: December 2014 ]
    Production of cytokines (such as IL-1beta, IL-6) in stimulated whole blood cultures.
  • Gene expression [ Time Frame: December 2014 ]
    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.
  • Immune cell profiling [ Time Frame: December 2014 ]
    Assessed by flow cytometry of whole blood.
  • Immune markers [ Time Frame: December 2014 ]
    Fasting plasma cytokines, hsCRP, and LPS/LPS-BP
  • Blood immune cell content [ Time Frame: December 2014 ]
    Assessed by hematological cell counts
  • Markers og glucose hemostasis [ Time Frame: December 2014 ]
    Measurement of plasma concentrations of Insulin, Proinsulin and HbA1c
  • Markers of one-carbon metabolism [ Time Frame: December 2015 ]
    Assessed by plasma homocystein, SAM/SAH and betain
  • Plasma adipokines [ Time Frame: December 2015 ]
    Leptin and adiponectin
  • 4-days precoded food diary [ Time Frame: December 2014 ]
    Assessment of dietary intake via food frequency questionnaire as a measure of compliance
  • n-3 fatty acid status [ Time Frame: At the end of the intervention periods ]
    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.
  • Alkyresorcinol [ Time Frame: At the end of the intervention periods ]
    Measured in plasma as a marker of compliance to the whole grain intervention.
  • 4-days precoded food diary [ Time Frame: December 2014 ]
    Assessment of dietary intake via food frequency questionnaire as a measure of compliance
  • n-3 fatty acid status [ Time Frame: December 2015 ]
    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.
  • Alkyresorcinol [ Time Frame: December 2015 ]
    Measured in plasma as a marker of compliance to the whole grain intervention.
 
The Effect of Whole Grain on Gut Microbiome and Metabolic Health
Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
  • Metabolic Disease
  • Injury of Gastrointestinal Tract
  • 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)
  • Other: 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)
  • Placebo Comparator: 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)
    Intervention: Other: Refined grain
  • Active Comparator: 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)
    Intervention: Other: Whole grain

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2015
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01731366
M206
Yes
Not Provided
Not Provided
Arne Astrup, University of Copenhagen
University of Copenhagen
Technical University of Denmark
Principal Investigator: Lotte Lauritzen, Associate professor University of Copenhagen
University of Copenhagen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP