Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jana Muchova
ORCID ID
http://orcid.org/0000-0001-7419-6913
Contact details
Institute of Medical Chemistry Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
81108
Slovakia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
V1.0
Study information
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
Acronym
ProWL
Study hypothesis
The 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
Ethical committee of Medical School, Comenius University in Bratislava, Slovakia, 14/04/2015
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Probiotic and fish oil combination on lipid subfractions and cardiovascular risk factors
Intervention
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.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/05/2015
Overall trial end date
01/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
40 participants
Participant 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)
Recruitment start date
08/09/2015
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Slovakia
Trial participating centre
Comenius University
Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Medical School
Sasinkova 2
Bratislava
81108
Slovakia
Sponsor information
Organisation
Cultech Ltd
Sponsor details
Unit 2-3
Christchurch Road
Baglan Industrial Park
Port Talbot
SA12 7BZ
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Cultech Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Assoc. Prof. Jana Muchova, PhD
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list