Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh
NCT ID: NCT02358122
Last Updated: 2015-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Refined wheat
Refined wheat grain, a variety of cereal foods providing no wholegrain
Refined wheat
A variety of cereal foods providing 0g/day wholegrain
Wholegrain wheat
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
Wholegrain rye
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
Interventions
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Wholegrain rye
A variety of cereal foods providing \>100g/day wholegrain from rye
Wholegrain wheat
A variety of cereal foods providing \>100g/day wholegrain from wheat
Refined wheat
A variety of cereal foods providing 0g/day wholegrain
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
65 Years
ALL
Yes
Sponsors
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Lantmännens Forskningsstiftelse
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Mette Bredal Kristensen
Associate Professor
References
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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.
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.
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.
Other Identifiers
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H-1-2014-062
Identifier Type: -
Identifier Source: org_study_id
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