The effects of a probiotic and vitamin D intervention in healthy adults on biochemical markers and metabolomic profiles
| ISRCTN | ISRCTN00310528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00310528 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/07/2010
- Registration date
- 21/07/2010
- Last edited
- 21/07/2010
- 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
Dr Lorraine Brennan
Scientific
Scientific
UCD Conway Institute
Dublin
D4
Ireland
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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. |
| Ethics approval(s) | UCD Research Ethics Committee approved on the 13th October 2006 (ref: HREC-39-06-Gibney) |
| Health condition(s) or problem(s) studied | Metabolic syndrome biomarkers |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | No secondary outcome measures |
| Overall study start date | 01/11/2006 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key inclusion criteria | 1. Healthy male and females aged 18 - 75 years 2. Free living 3. Fluent in English |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Ireland
Study participating centre
UCD Conway Institute
Dublin
D4
Ireland
D4
Ireland
Sponsor information
University College Dublin (UCD) (Ireland)
University/education
University/education
Belfield
Dublin
D4
Ireland
| Website | http://www.ucd.ie/ |
|---|---|
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Government
Department of Agriculture, Food and Fisheries (Ireland) - research grant under the Food Institutional Research Measure (ref: 06RDD417)
No information available
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 |
