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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03550365
Other study ID # 84/2010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2011
Est. completion date December 31, 2017

Study information

Verified date June 2018
Source University of Eastern Finland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2017
Est. primary completion date December 31, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Rye bran bread intervention
4 week dietary intervention rich in rye bran bread
Rye bread intervention
4 week dietary intervention rich in rye bread
Wheat bread diet
4 week dietary intervention rich in wheat bread as an active comparator for previous two interventions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Eastern Finland VTT Technical Research Centre of Finland

References & Publications (3)

Lappi J, Aura AM, Katina K, Nordlund E, Kolehmainen M, Mykkänen 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: — View Citation

Lappi J, Mykkänen H, Bach Knudsen KE, Kirjavainen P, Katina K, Pihlajamäki 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 — View Citation

Raninen K, Lappi J, Kolehmainen M, Kolehmainen M, Mykkänen 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 sympto — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary gastrointestinal symptoms intestinal discomfort measured by questionnaire 4 week dietary period
Secondary Glucose concentration fasting plasma glucose concentration (mmol/L) 4 week dietary period
Secondary Insulin concentration fasting serum insulin concentration (mU/L) 4 week dietary period
Secondary fecal microbiota fecal microbiota composition 4 week dietary period
Secondary Exhaled air exhaled air analysis for volatile organic compounds with solid phase (semiquantitative) microextraction and gas chromatography-mass spectrometry 4 week dietary period
Secondary highly sensitive C-reactive protein concentration of fasting hs-CRP (mg/L) 4 week dietary period
Secondary Interleukin 6 Concentration of fasting IL-6 (ug/mL) 4 week dietary period
Secondary Tumor necrosis factor alfa concentration of fasting TNF-alfa (pg/mL) 4 week dietary period
Secondary interleukin 1 receptor antagonist concentration of fasting IL-1Ra (ng/L) 4 week dietary period
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