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The effects of a probiotic and vitamin D intervention in healthy adults on biochemical markers and metabolomic profiles

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00310528
Enrollment
160
Registered
2010-07-21
Start date
2006-11-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome biomarkers Nutritional, Metabolic, Endocrine Metabolic syndrome

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. Tr

Sponsors

University College Dublin (UCD) (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy male and females aged 18 - 75 years 2. Free living 3. Fluent in English

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026