Grain Fibre and Gut Health (FIBREFECTS)

June 18, 2018 updated by: University of Eastern Finland

Grain Fibre Modification for Gut-mediated Health Effects

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.

Study Overview

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marjukka Kolehmainen, Professor, University of Eastern Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2012

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

When data is anonymised it has been planned to be shared. However, in current form, Finnish law does not allow sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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