NCT01719913

Brief 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 wash-out period. A total number of 60 participants will be included. Intervention: low vs high gluten intake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

October 24, 2012

Last Update Submit

December 4, 2013

Conditions

Metabolic DiseasesInjury of Gastrointestinal Tract

Outcome Measures

Primary Outcomes (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.

    Up to 3 years.

Secondary Outcomes (16)

  • Mean intestinal transit time

    Up to 2 years.

  • Gastrointestinal permeability.

    Up to 2 years.

  • Colonic fermentation

    Up to 2 years.

  • Blood pressure and pulse.

    Up to 1 year.

  • Saliva microbial flora

    Up to 2 years.

  • +11 more secondary outcomes

Other Outcomes (2)

  • 4 days precoded food diary.

    Up to 2 years.

  • Gastrointestinal symptoms.

    Up to 2 years.

Study Arms (2)

Low gluten

ACTIVE COMPARATOR

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)

Other: Low gluten

High gluten

PLACEBO COMPARATOR

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)

Other: High gluten

Interventions

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)

High gluten
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)

Low gluten

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29499850DERIVED

Related Links

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Oluf B Pedersen, MD, DMSCi,Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director, professor

Study Record Dates

First Submitted

October 24, 2012

First Posted

November 1, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations

DK(1)