The effects of yoghurt and its probiotics on features of the metabolic syndrome, intestinal function, bone metabolism and quality of life; a randomised controlled trial.
Phase 2
Recruiting
- Conditions
- Metabolic SyndromeCardiovascular - HypertensionMetabolic and Endocrine - DiabetesCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12612000033842
- Lead Sponsor
- Professor Richard Prince
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
1. Minimal usual probiotic intake (consuming less than 400 g yoghurt per week, and not taking probiotic supplements); AND 2. BMI greater than 25 kg/m2; AND 3. Waist circumference greater than 94 cm in men and 80cm in women OR blood pressure >120/80 mmHg
Exclusion Criteria
1. Unlikely to complete the 6 week study
2. Intolerance to dairy foods
3. Unable to attend the study centre on 4 occasions over 9 weeks
4. Current antibiotic use
5. Patients on immunosuppressive
6. Type two diabetes requiring pharmaceutical treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in low density lipoprotein cholesterol assessed by blood analysis[Baseline and 6 weeks after intervention commencement];Change in systolic blood pressure assessed by sphygmomanometer[Baseline and 6 weeks after intervention commencement];Change in fasting glucose concentration assessed by blood analysis[Baseline and 6 weeks after intervention commencement]
- Secondary Outcome Measures
Name Time Method Blood glucose control as indicated by glycated haemoglobin, insulin concentration and fasting blood glucose level.[Baseline and 6 weeks after intervention commencement];Gastrointestinal symptoms as assessed using the Irritable Bowel Syndrome Severity Scale[Baseline and 3 and 6 weeks after intervention commencement]