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

Completed

• Conditions: Metabolic syndrome biomarkers; Nutritional, Metabolic, Endocrine; Metabolic syndrome

• Registration Number: ISRCTN00310528
• Lead Sponsor: niversity College Dublin (UCD) (Ireland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the following markers at the end of the 4 week intervention:<br>1. Leptin<br>2. Resistin<br>3. Adiponectin<br>4. Interleukin-6 (IL-6)<br>5. C-reactive protein (CRP)<br>6. Tumour necrosis factor-alpha (TNFa)<br>7. Insulin<br>8. C-peptide<br>9. 25-hydroxy vitamin D (25(OH)D)<br>10. Triglyceride (TAG)<br>11. Non-esterfied fatty acids (NEFA)<br>12. Glucose

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures