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Register:	ISRCTN
Last refreshed on:	11 February 2019
Main ID:	ISRCTN41452843
Date of registration:	21/03/2018
Prospective Registration:	No
Primary sponsor:	Cultech Ltd
Public title:	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
Scientific title:	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
Date of first enrolment:	08/09/2015
Target sample size:	40
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN41452843
Study type:	Interventional
Study design:	Randomised double-blind placebo-controlled study (Prevention)
Phase:

Countries of recruitment
Slovakia

Contacts

Name:	Jana Muchova
Address:	Institute of Medical Chemistry Biochemistry and Clinical Biochemistry Medical School Comenius University Sasinkova 2 81108 Bratislava Slovakia
Telephone:
Email:
Affiliation:

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Address:
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Key inclusion & exclusion 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
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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Probiotic and fish oil combination on lipid subfractions and cardiovascular risk factors
Nutritional, Metabolic, Endocrine

Intervention(s)

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. acidophilus CUL60, L. acidophilus CUL21, L. plantarum CUL66, B. bifidum CUL20 and B. lactis CUL34) at 10×10^10 cfu per day and fish oil capsule containing 1 500 mg of a total omega 3 fatty acids per day
2. Placebo intervention: maltodextrin and sunflower oil capsules

All participants will be on a calorie restricted diet for 8 weeks followed by their standard diet for 4 weeks. Participants will provide venous blood samples and body composition measurements at baseline, 8 and 12 weeks. Participants will need to complete food and health diaries.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

V1.0

Source(s) of Monetary Support

Cultech Ltd (UK)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethical committee of Medical School, Comenius University in Bratislava, Slovakia, 14/04/2015

Results

Results available:	Yes
Date Posted:
Date Completed:	01/04/2016
URL:

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