Ignite Creation Date:
2024-05-05 @ 9:51 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00971113
Status:
COMPLETED
Last Update Posted:
2009-09-03
First Post:
2009-09-02
Brief Title:
Prebiotic Effect of a Jelly Containing Short Chain Fructo-Oligosaccharides and Sideritis Euboea Extract
Sponsor:
Harokopio University
Organization:
Harokopio University
Study Overview
Official Title:
Impact of a Jelly Containing Short Chain Fructo-oligosaccharides and Sideritis Euboea Extract on Human Gut Microflora
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The human intestinal microflora is characterized as a complex and dynamic microbial ecosystem with crucial contribution to our nutrition and welfare Health-promoting genera such as Bifidobacterium spp and Lactobacillus spp play a key role in digestion of nutrients production of short chain fatty acids and vitamins inhibition of harmful bacteria immunostimulation reduction of blood cholesterol and ammonia levels and restoration of normal flora after antibiotic therapy Proteolytic species such as toxin-producing clostridia and toxigenic E coli are considered as potential pathogens with detrimental effects to human host
Recently part of novel food research is directing towards the concept of prebiotics eg food ingredients that are not hydrolyzed by the human gastrointestinal tract and beneficially affect the host by selectively stimulating the growth andor activity of one or limited number of bacteria in the colon that can improve host health
Fructo-oligosaccharides and inulin are considered as the most extensively studied and well-established prebiotics In vitro and in vivo data suggest the bifidogenic effect of inulin and oligofructose which can be attributed to their selective fermentation by Bifidobacterium species Due to their documented prebiotic properties both inulin and FOS are increasingly applied in novel food product development through the fortification of commonly ingested foodstuffs
The aim of this study is to evaluate the in vivo prebiotic effect of a functional food containing short-chain fructo-oligosaccharides sc-FOS and Sideritis euboea extract on the faecal microflora composition of healthy human volunteers
Recently part of novel food research is directing towards the concept of prebiotics eg food ingredients that are not hydrolyzed by the human gastrointestinal tract and beneficially affect the host by selectively stimulating the growth andor activity of one or limited number of bacteria in the colon that can improve host health
Fructo-oligosaccharides and inulin are considered as the most extensively studied and well-established prebiotics In vitro and in vivo data suggest the bifidogenic effect of inulin and oligofructose which can be attributed to their selective fermentation by Bifidobacterium species Due to their documented prebiotic properties both inulin and FOS are increasingly applied in novel food product development through the fortification of commonly ingested foodstuffs
The aim of this study is to evaluate the in vivo prebiotic effect of a functional food containing short-chain fructo-oligosaccharides sc-FOS and Sideritis euboea extract on the faecal microflora composition of healthy human volunteers
Detailed Description:
In this randomized double-blinded placebo-controlled clinical study we aimed to evaluate the in vivo prebiotic effects of a functional food containing short-chain fructo-oligosaccharides sc-FOS and Sideritis euboea extract on human faecal microflora Sixty-four healthy volunteers 26 men and 38 women age range22-51 were assigned to consume daily a jelly containing 5 g sc-FOS and 03 g Seuboea extract or a placebo for 30 d Stool samples were collected prior to the study on day 15 and 30 of intervention and 2 weeks after Enumeration of faecal bacteria was performed by plate count techniques Gastrointestinal side effects were recorded during the treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None