Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/07/2010
Date assigned
21/07/2010
Last edited
21/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lorraine Brennan

ORCID ID

Contact details

UCD Conway Institute
Dublin
D4
Ireland

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

http://www.ucd.ie/

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

Publication citations

Additional files

Editorial Notes