Metabolic Disease3GNCT01731366
The Effect of Whole Grain on Gut Microbiome and Metabolic Health
A study testing Whole grain and Refined grain in people with Metabolic Disease and Injury of Gastrointestinal Tract, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Injury of Gastrointestinal Tract
- What is being tested?
- Whole grain and Refined grain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, University of Copenhagen
Fredriksberg, 1958
About this study
Official title: 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.
Read the detailed 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.
- Being tested
- Whole grain, Refined grain
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grainOther
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 grainOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Refined grain | Placebo comparator | 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) Receives: Other: Refined grain |
| Whole grain | Active comparator | 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) Receives: Other: Whole grain |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
Measured: At the end of the intervention periods
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.
Measured: At the end of the intervention periods
Secondary outcomes (18)
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.
Measured: At the end of the intervention periods
Gastrointestinal permeability, Lactulose/ mannitol ratio
5 hours urine collection following intake of lactulose and mannitol
Measured: At the end of the intervention periods
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)
Measured: At the end of the intervention periods
Saliva microbial flora
Determination of fasting microbial composition of flora.
Measured: At the end of the intervention periods
Blood pressure
Measurement of supine systolic and diastolic blood pressure (3 times)
Measured: At the end of the intervention periods
Appetite hormones
Determination of different appetite hormones in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast)
Measured: At the end of the intervention periods
Blood lipid profile
Measurement of different blood lipids in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast)
Measured: At the end of the interventions periods
Body composition
Measurement of body fat mass and percentage via bio-impedance
Measured: At the end of the intervention periods
Subjective appetite sensation
Assessment of subjective appetite sensation via visual analogue scales
Measured: At the end of the intervention periods
Energy intake
Assessment of energy intake at an ad libitum meal 3 hours after a standard breakfast
Measured: At the end of the intervention periods
Ex vivo cytokine production
Production of cytokines (such as IL-1beta, IL-6) in stimulated whole blood cultures.
Measured: At the end of the intervention periods
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.
Measured: At the end of the intervention periods
Immune cell profiling
Assessed by flow cytometry of whole blood.
Measured: At the end of the intervention periods
Immune markers
Fasting plasma cytokines, hsCRP, and LPS/LPS-BP
Measured: At the end of the intervention periods
Blood immune cell content
Assessed by hematological cell counts
Measured: At the end of the intervention periods
Markers og glucose hemostasis
Measurement of plasma concentrations of Insulin, Proinsulin and HbA1c
Measured: At the end of the intervention periods
Markers of one-carbon metabolism
Assessed by plasma homocystein, SAM/SAH and betain
Measured: At the end of the intervention periods
Plasma adipokines
Leptin and adiponectin
Measured: December 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Lotte Lauritzen, Associate professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731366
- Sponsor's protocol ID
- M206
- Acronym
- 3G
- Status last verified
- Sep 2014
- First submitted
- 15 Nov 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lind MV, Lauritzen L, Vestergaard H, Hansen T, Pedersen O, Kristensen M, Ross AB. One-carbon metabolism markers are associated with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):402-410. doi: 10.1016/j.numecd.2018.01.005. Epub 2018 Jan 31.
PubMed 29499850Roager HM, Vogt JK, Kristensen M, Hansen LBS, Ibrugger S, Maerkedahl RB, Bahl MI, Lind MV, Nielsen RL, Frokiaer H, Gobel RJ, Landberg R, Ross AB, Brix S, Holck J, Meyer AS, Sparholt MH, Christensen AF, Carvalho V, Hartmann B, Holst JJ, Rumessen JJ, Linneberg A, Sicheritz-Ponten T, Dalgaard MD, Blennow A, Frandsen HL, Villas-Boas S, Kristiansen K, Vestergaard H, Hansen T, Ekstrom CT, Ritz C, Nielsen HB, Pedersen OB, Gupta R, Lauritzen L, Licht TR. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial. Gut. 2019 Jan;68(1):83-93. doi: 10.1136/gutjnl-2017-314786. Epub 2017 Nov 1.
PubMed 29097438Lind MV, Madsen ML, Rumessen JJ, Vestergaard H, Gobel RJ, Hansen T, Lauritzen L, Pedersen OB, Kristensen M, Ross AB. Plasma Alkylresorcinols Reflect Gluten Intake and Distinguish between Gluten-Rich and Gluten-Poor Diets in a Population at Risk of Metabolic Syndrome. J Nutr. 2016 Oct;146(10):1991-1998. doi: 10.3945/jn.116.236398. Epub 2016 Sep 14.
PubMed 27629576
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health
- ClinicalTrials.gov ID
- NCT01731366
- Acronym / sponsor ID
- 3G / M206
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refined grain | Placebo comparator | Other: Refined grainRefined 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) |
| Whole grain | Active comparator | Other: Whole grainWhole 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole grainWhole 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 | Whole grain |
| Refined grainRefined 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) | Other | Refined grain |
Primary outcome
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.
18 secondary outcomes
Mean intestinal transit time
Time frame: At the end of the intervention periods
Gastrointestinal permeability, Lactulose/ mannitol ratio
Time frame: At the end of the intervention periods
Colonic fermentation
Time frame: At the end of the intervention periods
Saliva microbial flora
Time frame: At the end of the intervention periods
Blood pressure
Time frame: At the end of the intervention periods
Appetite hormones
Time frame: At the end of the intervention periods
Blood lipid profile
Time frame: At the end of the interventions periods
Body composition
Time frame: At the end of the intervention periods
Subjective appetite sensation
Time frame: At the end of the intervention periods
Energy intake
Time frame: At the end of the intervention periods
Ex vivo cytokine production
Time frame: At the end of the intervention periods
Gene expression
Time frame: At the end of the intervention periods
Immune cell profiling
Time frame: At the end of the intervention periods
Immune markers
Time frame: At the end of the intervention periods
Blood immune cell content
Time frame: At the end of the intervention periods
Markers og glucose hemostasis
Time frame: At the end of the intervention periods
Markers of one-carbon metabolism
Time frame: At the end of the intervention periods
Plasma adipokines
Time frame: December 2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Derived from this study: PubMed 29499850Lind MV, Lauritzen L, Vestergaard H, Hansen T, Pedersen O, Kristensen M, Ross AB. One-carbon metabolism markers are associated with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):402-410. doi: 10.1016/j.numecd.2018.01.005. Epub 2018 Jan 31.
- Derived from this study: PubMed 29097438Roager HM, Vogt JK, Kristensen M, Hansen LBS, Ibrugger S, Maerkedahl RB, Bahl MI, Lind MV, Nielsen RL, Frokiaer H, Gobel RJ, Landberg R, Ross AB, Brix S, Holck J, Meyer AS, Sparholt MH, Christensen AF, Carvalho V, Hartmann B, Holst JJ, Rumessen JJ, Linneberg A, Sicheritz-Ponten T, Dalgaard MD, Blennow A, Frandsen HL, Villas-Boas S, Kristiansen K, Vestergaard H, Hansen T, Ekstrom CT, Ritz C, Nielsen HB, Pedersen OB, Gupta R, Lauritzen L, Licht TR. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial. Gut. 2019 Jan;68(1):83-93. doi: 10.1136/gutjnl-2017-314786. Epub 2017 Nov 1.
- Derived from this study: PubMed 27629576Lind MV, Madsen ML, Rumessen JJ, Vestergaard H, Gobel RJ, Hansen T, Lauritzen L, Pedersen OB, Kristensen M, Ross AB. Plasma Alkylresorcinols Reflect Gluten Intake and Distinguish between Gluten-Rich and Gluten-Poor Diets in a Population at Risk of Metabolic Syndrome. J Nutr. 2016 Oct;146(10):1991-1998. doi: 10.3945/jn.116.236398. Epub 2016 Sep 14.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lotte Lauritzen, Associate professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grain and Refined grain in people with Metabolic Disease and Injury of Gastrointestinal Tract, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA-IR (time frame: At the end of the intervention periods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01731366, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.