Prebiotic Effect of a Jelly Containing Short Chain Fructo-Oligosaccharides and Sideritis Euboea Extract

NCT00971113 | Completed

• 1 other identifier: 05PAV 363
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 e.g. food ingredients that are not hydrolyzed by the human gastrointestinal tract and beneficially affect the host by selectively stimulating the growth and/or 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.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• to evaluate the in vivo prebiotic effect of an jelly containing sc-FOS and Sideritis euboea extract on the faecal microflora composition and to evaluate the effect of jelly containing sc-FOS and Sideritis euboea extract on gastrointestinal symptoms

  30d intervention and 2 wks follow-up

Study Arms (2)

sc-FOS+Sideritis euboea group

EXPERIMENTAL

Jelly supplemented with short chain fructooligosaccharides and Sideritis euboea extract

Dietary Supplement: sc-FOS and Sideritis euboea extract

placebo group

PLACEBO COMPARATOR

Jelly without short-chain fructooligosaccharides and Sideritis euboea

Dietary Supplement: sc-FOS and Sideritis euboea extract

Interventions

sc-FOS and Sideritis euboea extract DIETARY_SUPPLEMENT

dietary supplement: jelly with 5g sc-FOS and 0.3g Sideritis euboea extract per daily portion for 30 days placebo food: jelly with no sc-FOS and Sideritis euboea

placebo group; sc-FOS+Sideritis euboea group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subjects

You may not qualify if:

• History of gastrointestinal disease
• Chronic diseases (i.e.,diabetes,cardiovascular diseases, hyperlipidemia, autoimmune disorders)
• History of epileptic seizures
• Extreme dietary behaviours
• Consumption of antibiotics and other medication 2 months prior and during the investigation period

Sponsors & Collaborators

• Harokopio University: lead
• Hellenic Republic Ministry of Development: collaborator
• Jotis S.A. Food Industry: collaborator

Study Sites (1)

Harokopio University

Kallithea, Attica, 17671, Greece

Location

Study Officials

• Adamantini Kyriacou, Ass. Professor

  Harokopio University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: April 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 3, 2009

Record last verified: 2009-09

Locations

GR (1)