Probiotic and fish oil combination on lipid subfractions and cardiovascular risk factors Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants randomised to active or placebo group will be required to take two capsules twice a day for 12 weeks:
1. Active intervention: Lab4p probiotic consortium capsule (L. acidop
Sponsors
Cultech Ltd
Eligibility
Sex/Gender
All
Inclusion 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
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 11. Participants who had taken antibiotics within 4 weeks prior to enrolment 12. Participants with alcohol intakes > 14 units/week or 3 units/day 13. Participants fitted with any electronic implantable device (contraindicated for bioelectrical impedance analysis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood lipid profile (total cholesterol, LDL cholesterol, HDL, triacylglycerols), glucose, insulin and hsCRP levels are measured using the ADVIA 1800 Chemistry System at baseline, 8 and 12 weeks 2. HDL and LDL subfractions are determined using the Lipoprint® LDL and HDL systems at baseline, 8 and 12 weeks 3. Body composition measurements are determined using the InBody 230 at baseline, 8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Systolic and diastolic blood pressure are measured using blood pressure monitor at baseline, 8 and 12 weeks 2. Markers of oxidative stress, hormones and vitamins are determined by HPLC or ELISA assays at baseline, 8 and 12 weeks | — |
Countries
Slovakia
Outcome results
None listed