Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Probiotic, vitamin D
Primary outcome measures
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 trial start date
01/11/2006
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy male and females aged 18 - 75 years
2. Free living
3. Fluent in English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD Conway Institute
Dublin
D4
Ireland
Sponsor information
Organisation
University College Dublin (UCD) (Ireland)
Sponsor details
Belfield
Dublin
D4
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Agriculture, Food and Fisheries (Ireland) - research grant under the Food Institutional Research Measure (ref: 06RDD417)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary