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Metabolic Diseases3GNCT01719913

The Effect of Gluten on Gut Microbiome and Metabolic Health.

A study testing High gluten and Low gluten in people with Metabolic Diseases and Injury of Gastrointestinal Tract, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: To identify how specific changes of the gluten 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 interventions periods, separated by a 6-week… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
High gluten and Low gluten
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteDenmark
Study dates
Oct 2012to Nov 2013
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 OR
  • Abdominal obesity: waist circumference: men: ≥ 94cm; women: ≥ 80cm
  • No medically prescribed diet
  • Weight stable
  • Intense sporting activities less than 10 h/week
  • Alcohol consumption less than 14 units/week (female) and 21 units/week (male)
Show all 11Show fewer
  • Signed informed consent
  • Fasting plasma glucose from 6.1 mmol/l to 6.9 mmol/l
  • Reduced high density lipoprotein (HDL) cholesterol; HDL ≤ 1.03 mmol/L for men and ≤ 1.29 mmol/L for women
  • Increased triglyceride (TG) > 1.3 mmol/L
  • Systolic blood pressure > 130 mmHg

Who cannot join

  • Pharmacological treatment; 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
  • 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

  • The Novo Nordisk Foundation of Basic Metabolic Health, Section for Metabolic Genetics

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Gut, Grain and Greens (3G): The Effect of Gluten on Gut Microbiome and Metabolic Health.

Objective: To identify how specific changes of the gluten 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 interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included.

Intervention: low vs high gluten 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 gluten-poor diet (<5 g/d) in the active treatment period and a gluten-rich diet (>25 g/d) during the control period.

Measurements: Altered quantitative metagenomics at bacterial gene- and species levels is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, circulating appetite hormone levels,serum metabolomics, gastrointestinal transit time and intestinal permeability. Furthermore, selected control measures are included; 4-day food records and a study intervention dietary records.

Being tested
High gluten, Low gluten
Medical subject headings
Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High glutenOther

    Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)

  • Low glutenOther

    Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)

Study groups in NCT01719913
Study groupRoleWhat they receive
Low glutenActive comparatorPoor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
Receives: Other: Low gluten
High glutenPlacebo comparatorRefined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
Receives: Other: High gluten

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Altered quantitative metagenomics at bacterial gene- and species levels.

    Feces samples are collected according to standard operation procedures for subsequent standardized microbial DNA extraction. Microbial DNA will be subjected to sequencing, microbial gene analyses, taxonomy analyses including enterotypes known species and unknown meta-species and functional annotation.

    Measured: Up to 3 years.

Secondary outcomes (16)

  1. 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: Up to 2 years.

  2. Gastrointestinal permeability.

    Lactulose/mannitol ratio in urine after four hours collection following oral intake of lactulose and mannitol.

    Measured: Up to 2 years.

  3. Colonic fermentation

    Breath hydrogen after intake of standardized breakfast (30,60,90,120,180 minutes)

    Measured: Up to 2 years.

  4. Blood pressure and pulse.

    Systolic and diastolic blood pressure and heart beat rate are measured after 10 min of rest according to current standard operational procedure with an automatic blood pressure meter. Participants are instructed not to talk during the measurements.

    Measured: Up to 1 year.

  5. Saliva microbial flora

    Saliva is collected after the participants have taken a small piece of paraffin in their mouth and have chewed until the paraffin has turned into one coherent mass (approximately one minute). Participants are swallowing the produced saliva for that minute. After this, and for the next 3 minutes, saliva is collected in a cup and handed over to the study personnel. Saliva is stored at minus 80 degrees for later studies of saliva microbial flora and saliva biochemistry.

    Measured: Up to 2 years.

  6. Nasal fluid

    Nasal fluid is collected by a non-invasive methodology for in vivo measurement of an array of immunological signalling molecules in the nasal airway lining. The method is based on a standardized collection of mucosal airway fluid from both nostrils onto small sheets of filter papers with efficient absorption properties. The technique is highly reproducible, and used for measuring immunological mediators representing the immediate response ability of the mucosal immune system.

    Measured: Up to 3 years.

  7. Appetite hormones

    Glucagon like peptide 1 and 2, Gastric inhibitory polypeptide, peptide YY and Ghrelin.

    Measured: Up to 3 years.

  8. Celiac disease markers

    Levels of gliadin and Immunoglobulin A and G transglutaminase.

    Measured: Up to 1 year.

  9. Blood lipid profile

    Low density Lipoproteins, High density lipoproteins, Total Cholesterol, Very low density lipoproteins and Free fatty acids.

    Measured: Up to 2 years.

  10. Bioimpedance

    Body composition (lean body mass and fat mass) is measured by bio-electrical impedance using multi frequency Quadscan.

    Measured: Up to 1 year.

  11. Breath hydrogen.

    Breath hydrogen measurements are done before the intake of the standardized breakfast (at 30, 60, 90, 120, 180 minutes), as an indicator of colonic fermentation.

    Measured: Up to 2 years.

  12. Insulin

    Fasting insulin and post prandial at 30, 60, 90, 120 and 180 minutes after standardized meal.

    Measured: Up to 2 years.

  13. Glucose

    Fasting glucose and post prandial at 30, 60, 90, 120 and 180 minutes after standardized meal.

    Measured: Up to 2 years.

  14. C-peptide

    Fasting.

    Measured: Up to 2 years.

  15. Inflammatory makers

    High sensitive C-reactive protein, Interleukin 1, 6 and 10, Lipopolysaccharide- binding protein, Tumor necrosis factor - alfa.

    Measured: Up to 3 years.

  16. Anthropometric characteristics.

    Weight, height, sagittal height and waist circumference.

    Measured: Up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719913
Sponsor's protocol ID
NNF-CBMR 3861-34275
Acronym
3G
Status last verified
Dec 2013
First submitted
24 Oct 2012
Last updated
5 Dec 2013
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 29499850

Questions about this trial

What is this clinical trial studying?

A study testing High gluten and Low gluten in people with Metabolic Diseases 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Altered quantitative metagenomics at bacterial gene- and species levels. (time frame: Up to 3 years.). 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 NCT01719913, which also lists 1 linked publication.

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 5 Dec 2013.

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