ISRCTN41452843
Completed
Not Applicable
A study to investigate the effect of probiotics in combination with fish oil on metabolic risk factors in overweight and obese subjects following caloric restriction diet
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Probiotic and fish oil combination on lipid subfractions and cardiovascular risk factors
- Sponsor
- Cultech Ltd
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults aged \= 18 years
- •2\. BMI between 25 to 35 kg/m2
- •3\. Participants are willing to give written informed consent
- •4\. Participants who are willing to follow the caloric restricted diet for 8 weeks of the study period
- •5\. Participants who are willing to avoid the use of other weight loss products during the study period
- •6\. Participants who are willing to provide blood samples
- •7\. Participants who are willing to avoid other probiotic, fish oil or oily fish use for the duration of the study
Exclusion Criteria
- •1\. Participants who have BMI \= 24\.9 kg/m2 and \= 36 kg/m2
- •2\. Participants who are unable/unwilling to give written informed consent
- •3\. Participants who are not prepared to provide blood samples as required
- •4\. Participants with known or suspected food allergy or intolerance to one of the intervention products' components.
- •5\. Participants who refuse to stop taking any probiotics supplements, dairy probiotic product (yoghurt with biocultures, Acidophilus milk, kefir, Actimel, Yakult, etc) and omega 3/fish oil supplements apart from the intervention products during the study period
- •6\. Participants who have undergone bariatric surgery
- •7\. Participants with three months of weight instability before study enrolment or known history of eating disorders (anorexia nervosa, bulimia nervosa)
- •8\. Participants with diabetes mellitus 1st and 2nd type
- •9\. Participants with personal history of severe chronic diseases (cancer, HIV, kidney failure, liver damage, diagnosed gastrointestinal disorders, arthritis, chronic respiratory failure, etc)
- •10\. Pregnant or breastfeeding women or intending to become pregnant within next 3 months
Outcomes
Primary Outcomes
Not specified
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