Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Copenhagen
- Enrollment
- 75
- Primary Endpoint
- Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Refined wheat
Refined wheat grain, a variety of cereal foods providing no wholegrain
Intervention: Refined wheat (Other)
Wholegrain wheat
Wholegrain wheat grain, a variety of cereal foods providing >100g wheat wholegrain/day
Intervention: Wholegrain wheat (Other)
Wholegrain rye
Wholegrain rye grain, a variety of cereal foods providing >100g rye wholegrain/day
Intervention: Wholegrain rye (Other)
Outcomes
Primary Outcomes
Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)
Time Frame: Change from 0 to 6 weeks
Subjective sensations of gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)
Gut microbiota composition assessed using 16S in a single fecal sample
Time Frame: Change from 0 to 6 weeks
Gut microbiota compostion assessed using 16S in a single fecal sample
Secondary Outcomes
- Zonulin, fasting concentrations in plasma(Change from 0 to 6 weeks)
- Anthropometric masures(Change from 0 to 6 weeks)
- Blood pressure(Change from 0 to 6 weeks)
- Blood lipids, fasting concentrations of total, LDL and HDL cholesterol and triglyerides(Change from 0 to 6 weeks)
- Glucose metabolism, fasting concentrations of glucose, insulin and HbA1C as calculation of HOMA-IR(Change from 0 to 6 weeks)
- Low-grade inflammation, fasting concentrations of hsCRP, IL-6, IL-10, and TNF-a(Change from 0 to 6 weeks)
- Appetite sensation(Change from 0 to 6 weeks)
- Breath hydrogen assessed using a Hydrolyzer(Change from 0 to 6 weeks)
- Short chain fatty acids, fecal concentrations of short chain fatty acids(Change from 0 to 6 weeks)
- Fecal pH(Change from 0 to 6 weeks)
- Intestinal permeability, assessed by urinary excretion of lactulose and mannitol(Change from 0 to 6 weeks)
- Dietary intake, a weighted 4-day food record(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(Change from 0 to 6 weeks)
Investigators
Mette Bredal Kristensen
Associate Professor
University of Copenhagen