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 |
| Protocol serial number | V1.0 |
| Sponsor | Cultech Ltd |
| Funder | Cultech Ltd (UK) |
- 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
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
Scientific
Institute of Medical Chemistry Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
81108
Slovakia
 ORCID ID |
0000-0001-7419-6913 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | ProWL |
| Study objectives | 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(s) | Ethical committee of Medical School, Comenius University in Bratislava, Slovakia, 14/04/2015 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(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 |
| Key secondary outcome measure(s) |
1. Systolic and diastolic blood pressure are measured using blood pressure monitor at baseline, 8 and 12 weeks |
| Completion date | 01/04/2016 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 08/09/2015 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Slovakia
Study participating centre
Sasinkova 2
Bratislava
81108
Slovakia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Assoc. Prof. Jana Muchova, PhD |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/01/2019: The intention to publish date has been changed from 30/06/2018 to 31/12/2019
