Effect of symbiotic administration on selected health indices in a human volunteer trial (dietary intervention)

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN43435738
• Date of registration: 07/07/2006
• Primary sponsor: EU Commission (Belgium)
• Public title: Effect of symbiotic administration on selected health indices in a human volunteer trial (dietary intervention) N/A
• Date of first enrolment: Feb 17 2005
• Target sample size: 53 adult volunteers (12 men and 41 women)
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN43435738
• Study type: Interventional
• Study design: Randomised double-blind dietary (symbiotic) cross-over intervention study

Countries of recruitment

Estonia

Contacts

• Name: Marika Mikelsaar

Key inclusion & exclusion criteria

Inclusion criteria: 1. Wish to participate in the study
2. Aged 20-60 years
3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy)
4. Signed informed consent
Exclusion criteria: 1. History of any gastrointestinal disease
2. Use of any antimicrobial drug within last month
3. Use of any regular concomitant medication, including medical preparations
4. Pregnancy or breastfeeding
5. Food allergy

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Healthy adults

Intervention(s)

Symbiotic consumption versus placebo capsule. Volunteers were randomly allocated to receive either:
1. One sachet of prebiotic (6.6 g Raftilose®; P95) and two capsules of the freeze-dried probiotics (Lactobacillus fermentum ME-3, Lactobacillus paracasei 8700:2, Bifidobacterium longum 46; 3 x 10^9 colony forming units [CFU]) per day
2. Placebo (maltodextrin) twice a day for three weeks
After a two-week washout period, volunteers were crossed over to another three weeks of symbiotic or placebo administration.

Details of Joint Sponsor:
Estonian Science Foundation
Sihtasutus Eesti Teadusfond
Endla 4, Tallinn
Estonia
http://www.etf.ee/

Primary Outcome(s)

The primary outcome measure is to assess the effect of symbiotic intake on health indices, biochemical markers, and faecal microflora

Secondary Outcome(s)

1. To assess the health indices of healthy adults (body mass index, blood pressure, bone mineral density)
2. The self-reported questionnaire was applied containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency)
3. All subjects completed a modified semi-quantitative questionnaire about their nutritional habits
4. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, total cholesterol (TC), low-density lipoprotein-cholesterol (LDL), high-density lipoprotein-cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hsCRP) levels
5. To determine total antioxidative activity (TAA), total antioxidative status (TAS), oxidized low density lipoprotein (oxLDL), baseline diene conjugates of LDL (BDC-LDL) in blood samples
6. To determine in urine the content of 8-isoprostanes and biogenic amines
7. Faecal samples were analysed for presence of Helicobacter pylori antigen by the Helicobacter pylori stool antigen (HpSA) test (ImmunoCard STAT HpSA, Meridian Bioscience Europe, Italy)
9. Fluorescence in situ hybridisation (FISH) was used to monitor changes in faecal microflora after consumption of synbiotic

Secondary ID(s)

96/94

Source(s) of Monetary Support

1. EU Commission 2. Estonian Science Foundation (Estonia)

Secondary Sponsor(s)

N/A