Clinical trial NCT02358122: Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh
Official title: Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Diseases
Cardiovascular Diseases
Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Lantmännens Forskningsstiftelse
First posted: 2015-02-06
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)
timeFrame: Change from 0 to 6 weeks
measure: Gut microbiota composition assessed using 16S in a single fecal sample
timeFrame: Change from 0 to 6 weeks
Secondary outcomes:
measure: Anthropometric masures
timeFrame: Change from 0 to 6 weeks
measure: Blood pressure
timeFrame: Change from 0 to 6 weeks
measure: Blood lipids, fasting concentrations of total, LDL and HDL cholesterol and triglyerides
timeFrame: Change from 0 to 6 weeks
measure: Glucose metabolism, fasting concentrations of glucose, insulin and HbA1C as calculation of HOMA-IR
timeFrame: Change from 0 to 6 weeks
measure: Low-grade inflammation, fasting concentrations of hsCRP, IL-6, IL-10, and TNF-a
timeFrame: Change from 0 to 6 weeks
measure: Appetite sensation
timeFrame: Change from 0 to 6 weeks
measure: Breath hydrogen assessed using a Hydrolyzer
timeFrame: Change from 0 to 6 weeks
measure: Short chain fatty acids, fecal concentrations of short chain fatty acids
timeFrame: Change from 0 to 6 weeks
measure: Fecal pH
timeFrame: Change from 0 to 6 weeks
measure: Intestinal permeability, assessed by urinary excretion of lactulose and mannitol
timeFrame: Change from 0 to 6 weeks
measure: Zonulin, fasting concentrations in plasma
timeFrame: Change from 0 to 6 weeks
measure: Dietary intake, a weighted 4-day food record
timeFrame: Change from 0 to 6 weeks
measure: Compliance, measured by fasting plasma alkylresorcinol concentrations will be used as a biomarker of wholegrain wheat and rye intake
timeFrame: Change from 0 to 6 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Christensen L, Vuholm S, Roager HM, Nielsen DS, Krych L, Kristensen M, Astrup A, Hjorth MF. Prevotella Abundance Predicts Weight Loss Success in Healthy, Overweight Adults Consuming a Whole-Grain Diet Ad Libitum: A Post Hoc Analysis of a 6-Wk Randomized Controlled Trial. J Nutr. 2019 Dec 1;149(12):2174-2181. doi: 10.1093/jn/nxz198.
citation: Vuholm S, Nielsen DS, Iversen KN, Suhr J, Westermann P, Krych L, Andersen JR, Kristensen M. Whole-Grain Rye and Wheat Affect Some Markers of Gut Health without Altering the Fecal Microbiota in Healthy Overweight Adults: A 6-Week Randomized Trial. J Nutr. 2017 Nov;147(11):2067-2075. doi: 10.3945/jn.117.250647. Epub 2017 Sep 27.
citation: Suhr J, Vuholm S, Iversen KN, Landberg R, Kristensen M. Wholegrain rye, but not wholegrain wheat, lowers body weight and fat mass compared with refined wheat: a 6-week randomized study. Eur J Clin Nutr. 2017 Aug;71(8):959-967. doi: 10.1038/ejcn.2017.12. Epub 2017 Mar 22.