Overview

This trial is active, not recruiting.

Conditions metabolic disease, injury of gastrointestinal tract
Treatments whole grain, refined grain
Sponsor University of Copenhagen
Collaborator Technical University of Denmark
Start date August 2012
End date February 2014
Trial size 60 participants
Trial identifier NCT01731366, M206

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 wash-out period. A total of 60 participants will be included.

Intervention: low vs. high whole grain intake.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (investigator)
Arm
(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)
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)
(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)
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)

Primary Outcomes

Measure
HOMA-IR
time frame: At the end of the intervention periods
Metagenomic profile
time frame: At the end of the intervention periods

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health
Principal investigator Lotte Lauritzen, Associate professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University of Copenhagen.