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

This study has been completed.
Sponsor:
Collaborators:
Hellenic Republic Ministry of Development
Jotis S.A. Food Industry
Information provided by:
Harokopio University
ClinicalTrials.gov Identifier:
NCT00971113
First received: September 2, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy Adult Subjects
Dietary Supplement: sc-FOS and Sideritis euboea extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of a Jelly Containing Short Chain Fructo-oligosaccharides and Sideritis Euboea Extract on Human Gut Microflora

Further study details as provided by Harokopio University:

Primary Outcome Measures:
  • 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 [ Time Frame: 30d intervention and 2 wks follow-up ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sc-FOS+Sideritis euboea group
Jelly supplemented with short chain fructooligosaccharides and Sideritis euboea extract
Dietary Supplement: sc-FOS and Sideritis euboea extract

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 Comparator: placebo group
Jelly without short-chain fructooligosaccharides and Sideritis euboea
Dietary Supplement: sc-FOS and Sideritis euboea extract

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


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 range:22-51) were assigned to consume daily a jelly containing 5 g sc-FOS and 0.3 g S.euboea 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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult subjects

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971113

Locations
Greece
Harokopio University
Kallithea, Attica, Greece, 17671
Sponsors and Collaborators
Harokopio University
Hellenic Republic Ministry of Development
Jotis S.A. Food Industry
Investigators
Study Director: Adamantini Kyriacou, Ass. Professor Harokopio University
  More Information

No publications provided

Responsible Party: Kyriacou Adamantini, Lecturer, Harokopio University
ClinicalTrials.gov Identifier: NCT00971113     History of Changes
Other Study ID Numbers: 05PAV 363
Study First Received: September 2, 2009
Last Updated: September 2, 2009
Health Authority: Greece: Ethics Committee

ClinicalTrials.gov processed this record on July 23, 2014