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
About this trial
This is an interventional other trial for Intestinal Disorder
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
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
NCT ID
NCT03550365
First Posted
May 14, 2018
Last Updated
June 18, 2018
Sponsor
University of Eastern Finland
Collaborators
VTT Technical Research Centre of Finland
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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