Effect of symbiotic administration on selected health indices in a human volunteer trial (dietary intervention)
| ISRCTN | ISRCTN43435738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43435738 |
| Secondary identifying numbers | 96/94 |
- Submission date
- 16/06/2006
- Registration date
- 07/07/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Marika Mikelsaar
Scientific
Scientific
Ravila 19
Tartu
50411
Estonia
| Phone | +372 (0)7 374 179 |
|---|---|
| marika.mikelsaar@ut.ee |
Study information
| Study design | Randomised double-blind dietary (symbiotic) cross-over intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The consumption of probiotic and prebiotic agents' influence on the human gastrointestinal ecosystem that may manifest the possible shifts in health indices in response to symbiotic intake. |
| Ethics approval(s) | Approved by the Ethics Review Committee on Human Research of the University of Tartu on 21/08/2001, reference number: 96/94 |
| Health condition(s) or problem(s) studied | Healthy adults |
| Intervention | 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/ |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure is to assess the effect of symbiotic intake on health indices, biochemical markers, and faecal microflora |
| Secondary outcome measures | 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 |
| Overall study start date | 17/02/2005 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 53 adult volunteers (12 men and 41 women) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/02/2005 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Estonia
Study participating centre
Ravila 19
Tartu
50411
Estonia
50411
Estonia
Sponsor information
EU Commission (Belgium)
Government
Government
European Commission Research Directorate-General
Commission Officer Isabelle de Froidmont-Görtz
Directorate E-Biotechnology, Agriculture and Food Research
Unit E2-Food Quality
B-1049
Brussels
SDME 8/31
Belgium
| Phone | +32 (0)2 296 8571 |
|---|---|
| isabelle.de-froidmont-goertz@cec.eu.int | |
| Website | http://ec.europa.eu/research |
"ROR" |
https://ror.org/00k4n6c32 |
Funders
Funder type
Government
EU Commission
No information available
Estonian Science Foundation (Estonia)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Estonian Science Foundation, ETF
- Location
- Estonia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
