Overview

This trial is active, not recruiting.

Conditions gastrointestinal diseases, cardiovascular diseases, obesity
Treatments wholegrain rye, wholegrain wheat, refined wheat
Sponsor University of Copenhagen
Collaborator Lantmännens Forskningsstiftelse
Start date September 2014
End date December 2014
Trial size 75 participants
Trial identifier NCT02358122, H-1-2014-062

Summary

A dietary intervention study designed as a randomized, controlled, parallel intervention of 6-weeks duration. A total of 75 participants will be included in the study and randomly allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye). Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood sampling, dietary assessment and a meal challenge will be done before (week 0) and after (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in concerning satisfaction with diet and gastrointestinal symptoms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Refined wheat grain, a variety of cereal foods providing no wholegrain
refined wheat
A variety of cereal foods providing 0g/day wholegrain
(Experimental)
Wholegrain wheat grain, a variety of cereal foods providing >100g wheat wholegrain/day
wholegrain wheat
A variety of cereal foods providing >100g/day wholegrain from wheat
(Experimental)
Wholegrain rye grain, a variety of cereal foods providing >100g rye wholegrain/day
wholegrain rye
A variety of cereal foods providing >100g/day wholegrain from rye

Primary Outcomes

Measure
Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)
time frame: Change from 0 to 6 weeks
Gut microbiota composition assessed using 16S in a single fecal sample
time frame: Change from 0 to 6 weeks

Secondary Outcomes

Measure
Anthropometric masures
time frame: Change from 0 to 6 weeks
Blood pressure
time frame: Change from 0 to 6 weeks
Blood lipids, fasting concentrations of total, LDL and HDL cholesterol and triglyerides
time frame: Change from 0 to 6 weeks
Glucose metabolism, fasting concentrations of glucose, insulin and HbA1C as calculation of HOMA-IR
time frame: Change from 0 to 6 weeks
Low-grade inflammation, fasting concentrations of hsCRP, IL-6, IL-10, and TNF-a
time frame: Change from 0 to 6 weeks
Appetite sensation
time frame: Change from 0 to 6 weeks
Breath hydrogen assessed using a Hydrolyzer
time frame: Change from 0 to 6 weeks
Short chain fatty acids, fecal concentrations of short chain fatty acids
time frame: Change from 0 to 6 weeks
Fecal pH
time frame: Change from 0 to 6 weeks
Intestinal permeability, assessed by urinary excretion of lactulose and mannitol
time frame: Change from 0 to 6 weeks
Zonulin, fasting concentrations in plasma
time frame: Change from 0 to 6 weeks
Dietary intake, a weighted 4-day food record
time frame: Change from 0 to 6 weeks
Compliance, measured by fasting plasma alkylresorcinol concentrations will be used as a biomarker of wholegrain wheat and rye intake
time frame: Change from 0 to 6 weeks

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

Inclusion Criteria: - • Age: 30 - 65 years - Body mass index (BMI): 25 - 32 kg/m2 - Weight stable (<3 kg weight change during the last 6 months) - Apparently healthy - Informed consent signed - Freezer capacity for 2 weeks bread provision - Can attend all visits required for the study Exclusion Criteria: - • Smoking on a daily basis - Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study - Diagnosed with any form of diabetes or CVD - Reported chronic GI disorders - Antibiotic treatment 3 month before study start and during the study - Use of pre- or probiotic 1 month before study start and during the study - Lack of cooperation and adherence to the protocol - Use of prescription medication will be evaluated on an individual basis

Additional Information

Official title Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh
Description A dietary intervention study designed as a randomized, controlled, parallel intervention of 6-weeks duration. A total of 75 participants will be included in the study and randomly allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye). The randomization will be stratified according to sex and sex-specific median habitual cereal dietary fibre intake (16g/d for men and 13g/d for women). The randomization will be done by means of a randomization generator of the webpage (http://www.randomization.com). Recruitment and randomization will take place continuously during the study period, and therefore randomization will be done as mixed block randomization. During the intervention study, participants are instructed to substitute all cereal products (e.g. bread, breakfast cereals, pasta) of their diet with the provided study products. The amount of provided study products will match the average intake of carbohydrate-rich products of the Danish population, which corresponds to ~200g of bread and cereal products per day. The participants will eat the study products in an ad libitum manner and b instructed to avoid other cereals in their diet including cake, biscuits, ready made meals and fast foods with the exception of White rice whis is allowed 1-2 times per week. Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood sampling, dietary assessment and a meal challenge will be done before (week 0) and after (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in concerning satisfaction with diet and gastrointestinal symptoms.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by University of Copenhagen.