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

ISRCTN ISRCTN41452843
DOI https://doi.org/10.1186/ISRCTN41452843
Secondary identifying numbers V1.0
Submission date
02/03/2018
Registration date
21/03/2018
Last edited
24/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Hypercholesterolaemia (high blood cholesterol) is one of the risk factors for cardiovascular (heart) disease. Probiotics are live bacteria and yeasts promoted as having various health benefits. There is a growing evidence that some probiotic organisms lower cholesterol and may contribute to disease prevention. This study assesses the effect of probiotics in combination with fish oil on blood lipids (fats) and other markers of cardiovascular risk in obese and overweight adults following a calorie restricted diet.

Who can participate?
Overweight and obese adults aged 18 and over

What does the study involve?
Participants are randomly allocated to take either probiotics in combination with fish oil or placebo (dummy) capsules for 12 weeks. All participants are on a calorie restricted diet for 8 weeks followed by their standard diet for 4 weeks. Participants provide blood samples and their body composition is measured at the start of the study and after 8 and 12 weeks. Participants also complete food and health diaries.

What are the possible benefits and risks of participating?
Participants who receive probiotics in combination with fish oil may benefit from the improvement of their lipid profile and reduction of metabolic risk factors. There are no known risks to participants. Participants with food allergy or intolerance to any of the product components are excluded.

Where is the study run from?
Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Comenius University, Bratislava (Slovakia)

When is the study starting and how long is it expected to run for?
May 2015 to April 2016

Who is funding the study?
Cultech Ltd (UK)

Who is the mail contact?
Assoc. Prof. Jana Muchova, PhD

Contact information

Prof Jana Muchova
Scientific

Institute of Medical Chemistry Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
81108
Slovakia

ORCiD logoORCID ID 0000-0001-7419-6913

Study information

Study designRandomised double-blind placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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
Study acronymProWL
Study objectivesThe study aims to investigate the impact of a probiotic and fish oil combination on lipid subfractions and cardiovascular risk factors in overweight and obese subjects following 8 weeks calorie restricted diet.
Ethics approval(s)Ethical committee of Medical School, Comenius University in Bratislava, Slovakia, 14/04/2015
Health condition(s) or problem(s) studiedProbiotic and fish oil combination on lipid subfractions and cardiovascular risk factors
InterventionParticipants 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.
Intervention typeSupplement
Primary outcome measure1. 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 measures1. 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
Overall study start date01/05/2015
Completion date01/04/2016

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40 participants
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment08/09/2015
Date of final enrolment30/09/2015

Locations

Countries of recruitment

  • Slovakia

Study participating centre

Comenius University
Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Medical School
Sasinkova 2
Bratislava
81108
Slovakia

Sponsor information

Cultech Ltd
Industry

Unit 2-3
Christchurch Road
Baglan Industrial Park
Port Talbot
SA12 7BZ
United Kingdom

Website http://www.cultech.co.uk
ROR logo "ROR" https://ror.org/00555bk04

Funders

Funder type

Industry

Cultech Ltd (UK)

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Assoc. Prof. Jana Muchova, PhD

Editorial Notes

24/01/2019: The intention to publish date has been changed from 30/06/2018 to 31/12/2019