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Grain Fibre and Gut Health (FIBREFECTS)

Primary Purpose

Intestinal Disorder, Glucose Metabolism Disorders, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rye bran bread intervention
Rye bread intervention
Wheat bread diet
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intestinal Disorder

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Rye bran bread intervention

    Rye bread intervention

    Wheat bread intervention

    Arm Description

    4 week rye bran bread diet intervention with dietary fibre intake of 30g

    4 week rye bread diet intervention with dietary fibre intake of 30g

    4 week wheat bread diet intervention with dietary fibre intake of 5-20g prior to two other arms

    Outcomes

    Primary Outcome Measures

    gastrointestinal symptoms
    intestinal discomfort measured by questionnaire

    Secondary Outcome Measures

    Glucose concentration
    fasting plasma glucose concentration (mmol/L)
    Insulin concentration
    fasting serum insulin concentration (mU/L)
    fecal microbiota
    fecal microbiota composition
    Exhaled air
    exhaled air analysis for volatile organic compounds with solid phase (semiquantitative) microextraction and gas chromatography-mass spectrometry
    highly sensitive C-reactive protein
    concentration of fasting hs-CRP (mg/L)
    Interleukin 6
    Concentration of fasting IL-6 (ug/mL)
    Tumor necrosis factor alfa
    concentration of fasting TNF-alfa (pg/mL)
    interleukin 1 receptor antagonist
    concentration of fasting IL-1Ra (ng/L)

    Full Information

    First Posted
    May 14, 2018
    Last Updated
    June 18, 2018
    Sponsor
    University of Eastern Finland
    Collaborators
    VTT Technical Research Centre of Finland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03550365
    Brief Title
    Grain Fibre and Gut Health
    Acronym
    FIBREFECTS
    Official Title
    Grain Fibre Modification for Gut-mediated Health Effects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2011 (Actual)
    Primary Completion Date
    December 31, 2012 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Eastern Finland
    Collaborators
    VTT Technical Research Centre of Finland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Wholegrain fibre is known to affect on the gut health, but also may cause intestinal discomfort. Thus, many individuals may avoid the consumption of whole grain cereals in spite of their known health benefits, and may in this regard consume more restricted diets. In the preset study the aim was to technologically modify the cereal fibres to improve its usability and to maintain its health beneficial properties. The objective was to investigate intestinal fermentation of grain dietary fibre and associated effects on gut-mediated metabolic health, such as immunological health and adipose tissue function. The hypothesis was that whole grain products maintain their original beneficial health effects and may be better tolerable when the bran is technologically modified. Additionally, it was hypothesized that gut-mediated bioavailability of plant cell wall compounds and their metabolites affect the metabolic health through their immunomodulatory effects.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intestinal Disorder, Glucose Metabolism Disorders, Inflammation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rye bran bread intervention
    Arm Type
    Experimental
    Arm Description
    4 week rye bran bread diet intervention with dietary fibre intake of 30g
    Arm Title
    Rye bread intervention
    Arm Type
    Experimental
    Arm Description
    4 week rye bread diet intervention with dietary fibre intake of 30g
    Arm Title
    Wheat bread intervention
    Arm Type
    Active Comparator
    Arm Description
    4 week wheat bread diet intervention with dietary fibre intake of 5-20g prior to two other arms
    Intervention Type
    Other
    Intervention Name(s)
    Rye bran bread intervention
    Intervention Description
    4 week dietary intervention rich in rye bran bread
    Intervention Type
    Other
    Intervention Name(s)
    Rye bread intervention
    Intervention Description
    4 week dietary intervention rich in rye bread
    Intervention Type
    Other
    Intervention Name(s)
    Wheat bread diet
    Intervention Description
    4 week dietary intervention rich in wheat bread as an active comparator for previous two interventions
    Primary Outcome Measure Information:
    Title
    gastrointestinal symptoms
    Description
    intestinal discomfort measured by questionnaire
    Time Frame
    4 week dietary period
    Secondary Outcome Measure Information:
    Title
    Glucose concentration
    Description
    fasting plasma glucose concentration (mmol/L)
    Time Frame
    4 week dietary period
    Title
    Insulin concentration
    Description
    fasting serum insulin concentration (mU/L)
    Time Frame
    4 week dietary period
    Title
    fecal microbiota
    Description
    fecal microbiota composition
    Time Frame
    4 week dietary period
    Title
    Exhaled air
    Description
    exhaled air analysis for volatile organic compounds with solid phase (semiquantitative) microextraction and gas chromatography-mass spectrometry
    Time Frame
    4 week dietary period
    Title
    highly sensitive C-reactive protein
    Description
    concentration of fasting hs-CRP (mg/L)
    Time Frame
    4 week dietary period
    Title
    Interleukin 6
    Description
    Concentration of fasting IL-6 (ug/mL)
    Time Frame
    4 week dietary period
    Title
    Tumor necrosis factor alfa
    Description
    concentration of fasting TNF-alfa (pg/mL)
    Time Frame
    4 week dietary period
    Title
    interleukin 1 receptor antagonist
    Description
    concentration of fasting IL-1Ra (ng/L)
    Time Frame
    4 week dietary period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marjukka Kolehmainen, Professor
    Organizational Affiliation
    University of Eastern Finland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    When data is anonymised it has been planned to be shared. However, in current form, Finnish law does not allow sharing.
    Citations:
    PubMed Identifier
    25370913
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23674066
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28391735
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31136658
    Citation
    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.
    Results Reference
    derived

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    Grain Fibre and Gut Health

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