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11 February 2012
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| [ Print-friendly version ] |
| The effects of a probiotic and vitamin D intervention in healthy adults on biochemical markers and metabolomic profiles |
| ISRCTN | ISRCTN00310528 |
| ClinicalTrials.gov identifier | |
| Public title | The effects of a probiotic and vitamin D intervention in healthy adults on biochemical markers and metabolomic profiles |
| Scientific title | The effects of a probiotic and vitamin D intervention in healthy adults on biochemical markers and metabolomic profiles: a double-blind, randomised placebo-controlled trial carried out in two centres |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | The aim of this study is to investigate if a 4 week supplementation intervention with vitamin D or a probiotic alters biomarkers of the metabolic syndrome and the metabolomic profiles. |
| Lay summary | |
| Ethics approval | UCD Research Ethics Committee approved on the 13th October 2006 (ref: HREC-39-06-Gibney) |
| Study design | Double-blind randomised placebo-controlled trial |
| Countries of recruitment | Ireland |
| Disease/condition/study domain | Metabolic syndrome biomarkers |
| Participants - inclusion criteria |
1. Healthy male and females aged 18 - 75 years
2. Free living 3. Fluent in English |
| Participants - exclusion criteria |
1. Body mass index less than 18.5 or greater than 30.0 (kg/m^2)
2. Iron deficiency anaemia (haemoglobin less than 12 g/dl for males, less than 11 g/dl for females) 3. Any chronic or infectious disease and any prescribed medication for such (contraceptive pills were permitted) 4. Pregnant or lactating females 5. Persons using hormone replacement therapy |
| Anticipated start date | 01/11/2006 |
| Anticipated end date | 01/09/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 160 |
| Interventions |
The four treatment groups were defined as follows:
1. Treatment group 1: received daily vitamin D3 (15 µg) and probiotic (Lactobacillus salivarius 109 cfu/5 g sachets suspended in maltodextrin) 2. Treatment group 2: received daily vitamin D3 and placebo probiotic (maltodextrin) 3. Treatment group 3: received daily vitamin D3 placebo and probiotic 4. Treatment group 4: received daily vitamin D3 placebo and probiotic placebo The vitamin D3 and matching placebo were food grade and consumed in capsule form and were identical in appearance and taste, while the probiotic and probiotic/placebo (in powder form) was mixed with milk for consumption. Treatment duration: 4 weeks. |
| Primary outcome measure(s) |
Measurement of the following markers at the end of the 4 week intervention:
1. Leptin 2. Resistin 3. Adiponectin 4. Interleukin-6 (IL-6) 5. C-reactive protein (CRP) 6. Tumour necrosis factor-alpha (TNFa) 7. Insulin 8. C-peptide 9. 25-hydroxy vitamin D (25(OH)D) 10. Triglyceride (TAG) 11. Non-esterfied fatty acids (NEFA) 12. Glucose |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Department of Agriculture, Food and Fisheries (Ireland) - research grant under the Food Institutional Research Measure (ref: 06RDD417) |
| Trial website | |
| Publications | |
| Contact name | Dr Lorraine Brennan |
| Address | UCD Conway Institute |
| City/town | Dublin |
| Zip/Postcode | D4 |
| Country | Ireland |
| Sponsor | University College Dublin (UCD) (Ireland) |
| Address | Belfield |
| City/town | Dublin |
| Zip/Postcode | D4 |
| Country | Ireland |
| Sponsor website: | http://www.ucd.ie/ |
| Date applied | 14/07/2010 |
| Last edited | 21/07/2010 |
| Date ISRCTN assigned | 21/07/2010 |
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