Clinical Evaluation of the Effects of EpiCor Brand Yeast Fermentate (Made Using Saccharomyces Cerevisiae) on Digestive Comfort, Intestinal Barrier Function and Prebiotic Modulation of the Gut Microbiota.

Previous in vitro studies suggest that EpiCor is well fermented in the colon and has prebiotic potential. The repeated long-term administration of low doses of EpiCor in the Simulator of the Human Intestinal Microbial Ecosystem (SHIME) has shown that this product is able to induce gradual changes in the colonic environment by: i) being selectively fermented, leading to butyrate increase in the colon; ii) stimulating Lactobacilli growth in the lumen and adherence to the mucosal surface, and iii) decreasing potential pathogens. In addition, the fermentation-derived metabolites produced in the colon were shown to potentially benefit the host by decreasing cytokine levels in vitro. As a result, the investigators hypothesize that EpiCor may help to improve bowel function and generally contribute to enhanced gut health. Therefore, this pilot study is intended to assess the effects of long-term administration of EpiCor on a population with mild symptoms of intestinal dysfunction.
The primary objective of this exploratory pilot study is to assess the effect of long term administration of EpiCor on bowel function and gastrointestinal well-being, by means of validated questionnaires.
This study has 4 secondary objectives: 1) The first secondary objective of this study is to assess the protective effects of EpiCor on intestinal barrier function, by performing a gut sugar permeability test in combination with indomethacin challenge; 2) The second secondary objective is to assess the effects of EpiCor on intestinal barrier function, by measuring blood Zonulin and endotoxin levels in combination with indomethacin challenge; 3) The third secondary objective of this study is to assess the prebiotic properties of EpiCor by collecting fecal samples. The microbial community composition, lactate and SCFA profiles and proteolytic activity markers in feces will be determined. Proteolytic activity markers will also be measured in urine samples; 4) The fourth secondary objective of this study is to assess the effects of EpiCor on local and systemic immune system performance by measuring secretory IgA levels in feces and cytokines in blood.

开始日期2015-07-06

申办/合作机构

ProDigest BV

[+3]

NCT02604316

/ CompletedN/A

SATIN: Satiety Innovation, Study 2. Effect of Novel Fibres (Arabinoxylan and Beta-glucan) in Appetite, Metabolic and Gut Health.

The proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches.
Specifically in this protocol the investigators will address, in a short human intervention study the effect of a potentially satiating product on appetite, appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of the products in healthy obese and overweight participants in free living conditions.

开始日期2014-01-01

申办/合作机构

University of Aberdeen

[+10]

NCT01724411

/ CompletedN/A

SATIN: Satiety Innovation, Study 1

The proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches.
Specifically in this protocol we will address, in a short human intervention study the effect of a potentially satiating product on appetite, appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of the products in healthy obese and overweight volunteers in free living conditions.

开始日期2012-08-01

申办/合作机构

University of Aberdeen

[+10]

100 项与 ProDigest BV 相关的临床结果

登录后查看更多信息

0 项与 ProDigest BV 相关的专利（医药）

登录后查看更多信息

项与 ProDigest BV 相关的文献（医药）

2015-01-01·The journal of nutrition, health & aging3区 · 医学

Twelve-month consumption of a polyphenol extract from olive (Olea europaea) in a double blind, randomized trial increases serum total osteocalcin levels and improves serum lipid profiles in postmenopausal women with osteopenia

3区 · 医学

Article

作者: I Pinheiro ; Sam Possemiers ; R Filip ; MJ Davicco ; V Coxam ; Arne Heyerick ; G Raszewski

OBJECTIVES:

Osteoporosis is a skeletal disorder characterized by impaired bone turnover and compromised bone strength, thereby predisposing to increased risk of fracture. Preclinical research has shown that compounds produced by the olive tree (Olea europaea), may protect from bone loss, by increasing osteoblast activity at the expense of adipocyte formation. The aim of this exploratory study was to obtain a first insight on the effect of intake of an olive extract on bone turnover in postmenopausal women with decreased bone mass (osteopenia).

DESIGN AND SETTING:

For that, a double blind, placebo-controlled study was performed in which participants were randomly allocated to either treatment or placebo groups.

PARTICIPANTS:

64 osteopenic patients, with a mean bone mineral density (BMD) T-score between -1.5 and -2.5 in the lumbar spine (L2-L4) were included in the study.

INTERVENTION AND MEASUREMENTS:

PARTICIPANTS received for 12 months daily either 250 mg/day of olive extract and 1000 mg Ca (treatment) or 1000 mg Ca alone (placebo). Primary endpoints consisted of evaluation of bone turnover markers. Secondary endpoints included BMD measurements and blood lipid profiles.

RESULTS:

After 12 months, the levels of the pro-osteoblastic marker osteocalcin were found to significantly increase in the treatment group as compared to placebo. Simultaneously, BMD decreased in the placebo group, while remaining stable in the treatment group. In addition, improved lipid profiles were observed, with significant decrease in total- and LDL-cholesterol in the treatment group.

CONCLUSION:

This exploratory study supports preclinical observations and warrants further research by showing that a specific olive polyphenol extract (Bonolive®) affects serum osteocalcin levels and may stabilize lumbar spine BMD. Moreover, the improved blood lipid profiles suggest additional health benefits associated to the intake of the olive polyphenol extract.

Agro food industry hi-tech

Use of the Simulator of the Human Intestinal Microbial Ecosystem (SHIME) to study the fate of food ingredients and actives

作者: Van Den Abbeele, Pieter ; Marzorati, Massimo ; Gottardi, Davide

The development of novel food ingredients, supplements or drugs demands consistent studies to validate their mechanism of release, absorption and action.Human in vivo trials are the gold standard to test one or few compounds, but extensive screening of novel products is often unfeasible.As a result, in vitro models represent a suitable complementary tool to test the fate of novel ingredients and mols. in the gastrointestinal tract (GIT).In this review, we describe the main parameters of the harmonized in vitro static model and we further provide practical examples of the use of the Simulator of the Human Intestinal Microbial Ecosystem (SHIME) technol. for testing the fate of compounds delivered in the GIT.

Specific members of the human gut microbiome colonize wheat bran-based dietary platforms, thus driving the production of health-related microbial metabolites

作者: De Paepe, Kim ; Van den Wiele, Tom ; Van den Abbeele, Pieter ; Marzorati, Massimo

Over the recent years, the agro food industry has become increasingly aware of the potential to promote human health via functional foods through modulation of the human gut microbiome.Within each area along the colon, different communities exist: luminal microbiota, surface-attached mucosal microbiota, and microbiotaassocd. with insoluble dietary particles.Especially the latter two remain poorly investigated due to the inaccessibility in vivo, so that there is a strong need to develop laboratory models.In this respect, ProDigest (Ghent, Belgium) and Ghent University developed a unique technol., the Simulator of the Human Microbial Ecosystem (SHIME) to investigate the human gut microbiome and its potential modulation along the ascending, transverse and descending colon.This technol. was extended to not only simulate luminal but also mucosal microbes.A further innovation, was the simulation of microbesassocd. with insoluble dietary particles, more specifically wheat bran (= most concentrated source of insoluble dietary fiber in Western diet).In a series of incubations with microbiota derived from 10 human donors, wheat bran-attached microbial communities differed from the luminal microbiota, with large inter-individual differences.Depending on the donor, wheat bran yielded proportionally higher propionate or butyrate production, metabolites being correlated to health benefits.Clostridium cluster XIVa and, depending on the donor, Prevotella, Roseburia, Megamonas, Bifidobacterium and Bacteroides species were enriched on the wheat bran particles.Both species with the ability to serve as primary degraders of wheat bran components and other species depending on cross-feeding to obtain their energy were enriched on the wheat bran residue.In conclusion, the current study reveals the unique composition of microbial communities colonizing dietary particles.The developed in vitro models allow to unravel the response of the human gut microbiome to administration of dietary particles and its resulting contribution in preventing or reducing the risk of chronic diseases.

100 项与 ProDigest BV 相关的药物交易

登录后查看更多信息

100 项与 ProDigest BV 相关的转化医学

登录后查看更多信息