The Effect of Gluten on Gut Microbiome and Metabolic Health. (3G)

University of Copenhagen

Status: Completed

Conditions: Metabolic Diseases; Injury of Gastrointestinal Tract

Treatments: Other: High gluten; Other: Low gluten

Study type: Interventional

Funder types: Other

Identifiers

NCT01719913

NNF-CBMR 3861-34275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria, compulsory:

• 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

Inclusion criteria, minimum one of the following:

• 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

Exclusion Criteria:

• 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 design

60 participants in 2 patient groups, including a placebo group

Low gluten

Active Comparator group

Description:

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)

Treatment:

Other: Low gluten

High gluten

Placebo Comparator group

Description:

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)

Treatment:

Other: High gluten