- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03550365
Grain Fibre and Gut Health (FIBREFECTS)
Grain Fibre Modification for Gut-mediated Health Effects
Study Overview
Status
Intervention / Treatment
Detailed Description
Cereal foods are the most important source of dietary fibre in the Northern European diet. Epidemiological studies have repeatedly shown that diets rich in whole grain foods reduce the risk of type 2 diabetes mellitus and cardiovascular disease. Cereal fibre complex has been suggested as one of the main constituents behind the protective effects. The dietary fibre complex is composed of biopolymers and small molecular weight compounds, that formulate the structure, content and interactions which change during processing. It has been proposed, based on animal data, that the shift in gut microbiota communities is a potential mechanism linking dietary fibre with reduced diabetes risk. Today it is known that gut microbita is actively interacting with dietary fibre producing active functional compounds to the circulation, and thus contribute to health benefits of dietary fibre. The hypothesis that insoluble fibre is a major contributor of the protective effects of whole-grain type cereal foods emphasizes the importance of dietary fibre structure and the conversions of both carbohydrates and polyphenols in the large intestine. The importance of structural features of grain foods in relation to their protective effect against type 2 diabetes was also pointed out in the previous review. On the other hand, soluble arabinoxylo-oligosaccharides have been shown to be selectively fermented by bifidobacteria in in vitro studies, and may thus also be health-protective.
Large intestinal fermentation of the non-digested material causes both hydrolysis of the cell wall matrix and also liberation, further metabolism and absorption of the associated compounds, such as polyphenols. The interactions between dietary factors, gut microbiota and host metabolism are increasingly demonstrated to be important for maintaining homeostasis and health, but research into the role of fibre structure and phytochemicals in gut microbiota mediated signalling is in its early phases.The physiological effects of dietary fibre are dependent on the physico-chemical properties, which are mainly influenced by particle size, cell wall architecture, solubility, degree of polymerisation and substitution, distribution of side chains and degree of cross-linking of the polymers. Insoluble dietary fibres are generally more resistant to colonic fermentation than soluble dietary fibre. Solubility of dietary fibre has a major effect also on the bioavailability of fibre associated nutrients and phytochemicals. It has been showed in vitro that enzymatic solubilisation of insoluble dietary fibre stimulated the growth of bifidobacteria and lactobacilli. Additionally, it has been shown that the effect of wheat-bran derived arabinoxylo-oligosaccharides on SCFA production and bifidobacterial numbers in rat faeces depended on the average degree of polymerisation (avDP) of the AXOS preparations - the low avDP preparations increased colonic acetate and butyrate production and boosted the bifidobacteria, whereas the higher avDP preparation suppressed branched SCFA concentrations (a marker for protein fermentation). When, the prebiotic effect of whole-grain wheat and wheat bran breakfast cereals was compared in a human PCT, whole grain cereals proved to be more efficient prebiotics for bifidobacteria whereas ingestion of both products resulted in a significant increase in ferulic acid concentrations in blood.
The objective is to investigate intestinal fermentation of grain dietary fibre and associated effects on gut-mediated metabolic health, such as immunological health and adipose tissue function. Part of the population, however, suffers from discomfort of gastrointestinal tract after consumption of whole grain products, especially rye. The hypothesis is that whole grain products maintain their original beneficial health effects and may be better tolerable when the bran is technologically modified. Moreover, it is hypothesized that gut-mediated bioavailability of plant cell wall compounds and their metabolites affect the metabolic health through their immunomodulatory effects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI 23-30 kg/m2
- abdominally obese (waist circumference >90 cm (men)/ >80 cm (women))
- gastrointestinal symptoms
Exclusion Criteria:
- celiac diseases
- extended allergies
- exceptional diets
- IBD patients
- recent (2 mo) use of antibiotic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rye bran bread intervention
4 week rye bran bread diet intervention with dietary fibre intake of 30g
|
4 week dietary intervention rich in rye bran bread
|
Experimental: Rye bread intervention
4 week rye bread diet intervention with dietary fibre intake of 30g
|
4 week dietary intervention rich in rye bread
|
Active Comparator: Wheat bread intervention
4 week wheat bread diet intervention with dietary fibre intake of 5-20g prior to two other arms
|
4 week dietary intervention rich in wheat bread as an active comparator for previous two interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gastrointestinal symptoms
Time Frame: 4 week dietary period
|
intestinal discomfort measured by questionnaire
|
4 week dietary period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose concentration
Time Frame: 4 week dietary period
|
fasting plasma glucose concentration (mmol/L)
|
4 week dietary period
|
Insulin concentration
Time Frame: 4 week dietary period
|
fasting serum insulin concentration (mU/L)
|
4 week dietary period
|
fecal microbiota
Time Frame: 4 week dietary period
|
fecal microbiota composition
|
4 week dietary period
|
Exhaled air
Time Frame: 4 week dietary period
|
exhaled air analysis for volatile organic compounds with solid phase (semiquantitative) microextraction and gas chromatography-mass spectrometry
|
4 week dietary period
|
highly sensitive C-reactive protein
Time Frame: 4 week dietary period
|
concentration of fasting hs-CRP (mg/L)
|
4 week dietary period
|
Interleukin 6
Time Frame: 4 week dietary period
|
Concentration of fasting IL-6 (ug/mL)
|
4 week dietary period
|
Tumor necrosis factor alfa
Time Frame: 4 week dietary period
|
concentration of fasting TNF-alfa (pg/mL)
|
4 week dietary period
|
interleukin 1 receptor antagonist
Time Frame: 4 week dietary period
|
concentration of fasting IL-1Ra (ng/L)
|
4 week dietary period
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marjukka Kolehmainen, Professor, University of Eastern Finland
Publications and helpful links
General Publications
- Lappi J, Mykkanen H, Bach Knudsen KE, Kirjavainen P, Katina K, Pihlajamaki J, Poutanen K, Kolehmainen M. Postprandial glucose metabolism and SCFA after consuming wholegrain rye bread and wheat bread enriched with bioprocessed rye bran in individuals with mild gastrointestinal symptoms. Nutr J. 2014 Nov 4;13:104. doi: 10.1186/1475-2891-13-104.
- Lappi J, Aura AM, Katina K, Nordlund E, Kolehmainen M, Mykkanen H, Poutanen K. Comparison of postprandial phenolic acid excretions and glucose responses after ingestion of breads with bioprocessed or native rye bran. Food Funct. 2013 Jun;4(6):972-81. doi: 10.1039/c3fo60078e. Epub 2013 May 14.
- Raninen K, Lappi J, Kolehmainen M, Kolehmainen M, Mykkanen H, Poutanen K, Raatikainen O. Diet-derived changes by sourdough-fermented rye bread in exhaled breath aspiration ion mobility spectrometry profiles in individuals with mild gastrointestinal symptoms. Int J Food Sci Nutr. 2017 Dec;68(8):987-996. doi: 10.1080/09637486.2017.1312296. Epub 2017 Apr 9. Erratum In: Int J Food Sci Nutr. 2017 Sep;68(6):i.
- Keski-Rahkonen P, Kolehmainen M, Lappi J, Micard V, Jokkala J, Rosa-Sibakov N, Pihlajamaki J, Kirjavainen PV, Mykkanen H, Poutanen K, Gunter MJ, Scalbert A, Hanhineva K. Decreased plasma serotonin and other metabolite changes in healthy adults after consumption of wholegrain rye: an untargeted metabolomics study. Am J Clin Nutr. 2019 Jun 1;109(6):1630-1639. doi: 10.1093/ajcn/nqy394.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 84/2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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