NCT02358122

Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gastrointestinal Diseases
• Cardiovascular Diseases
• Obesity

Interventions

Type	Name	Description
OTHER	Wholegrain rye	A variety of cereal foods providing \>100g/day wholegrain from rye
OTHER	Wholegrain wheat	A variety of cereal foods providing \>100g/day wholegrain from wheat
OTHER	Refined wheat	A variety of cereal foods providing 0g/day wholegrain

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2015-02-06
• Last updated: 2015-02-06