Effect of novel probiotic food supplement on elevated cardiometabolic and inflammatory markers on clinically asymptomatic volunteers.

• Register: ISRCTN
• Last refreshed on: 5 January 2021
• Main ID: ISRCTN55339917
• Date of registration: 12/03/2015
• Prospective Registration: No
• Primary sponsor: GIE Eurasanté (France)
• Public title: Effect of novel probiotic food supplement on elevated cardiometabolic and inflammatory markers on clinically asymptomatic volunteers.
• Scientific title: Effect of novel probiotic food supplement on elevated cardiometabolic and inflam¬matory markers on clinically asymptomatic volunteers (a randomized blinded study).
• Date of first enrolment: 10/10/2014
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN55339917
• Study type: Interventional
• Study design: Randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Estonia

Contacts

• Name: Tiiu Kullisaar

Key inclusion & exclusion criteria

Inclusion criteria:
1. A written informed consent
2. Aged between 40 - 70 years
3. No known health problems
4. Total cholesterol higher than 5.3 mmol/L or LDL-chol higher than 3.0mmol/L or triglycerides higher than 1.7 mmol/L or total cholesterol/HDL higher than 4 or LDL/HDL higher than 3 or glycated Hb higher than 5.7% or hsCRP higher than 1,0 mg/L or homocysteine higher than 11 micromol/L
5. No use of any concomitant treatment which could influence the evaluation of the efficacy and the tolerability of the investigational study product, including lipid lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid), supplementation with e.g. omega-3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, vitamins, soy protein, psyllium seed husk or probiotics/prebiotics within the preceding at least 3 weeks
6. Willingness to maintain a stable diet and physical activity level

Exclusion criteria:
1. Pregnancy and breastfeeding
2. History of gastrointestinal disease
3. Food allergy
4. Diabetes
5. Acute infection within the last 3 weeks prior to enrolment
6. Use of any antimicrobial agents within the preceding 2 months
7. Use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 3 weeks
8. Intolerance to the investigational product / its ingredients
9. Any kind of concurrent disease which could influence the evaluation of the efficacy
10. Tolerability of the investigational study product
11. Any serious organ or systemic diseases
12. Eating disorder
13. Extensive exercise
14. Genetic hyperlipidemia
15. Drug or alcohol abuse
16. Active weight loss > 5 kg in prior 3 months participation in other studies within the last 30 days /
during the study


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Elevated values of blood lipids, oxidative stress, inflammation and blood glucose related indices.
Nutritional, Metabolic, Endocrine

Intervention(s)

The consumption of a food supplement Reg?Activ Cholesterol: daily dose two capsules for 4 and 8 weeks vs consumption of control capsules

Primary Outcome(s)

1. LDL cholesterol
2. Triglycerides
3. Glycated hemoglobin
4. Oxidized LDL
5. Isoprostanes
Measured at baseline, at 4th week from the beginning of the trial, 8th week from the beginning of the trial.

Secondary Outcome(s)

1. HsCRP
2. Homocysteine
3. IL-6
4. TG/HDL ratio
5. Oxidative stress index
6. Proinflammatory cytokines
7. Adiponectin
8. Antiinflammatory cytokines
Measured at baseline, at 4th week from the beginning of the trial, 8th week from the beginning of the trial.

Secondary ID(s)

237/M-15

Source(s) of Monetary Support

University of Tartu, Faculty of Medicine, Department of Biochemistry (Estonia), GIE Eurasanté (France)

Ethics review

Status:
Approval date:
Contact:

Human Research Ethics Review Committee, University of Tartu, 19/05/2014, ref: 237/M-15

Results

• Results available: Yes
• Date Completed: 31/03/2015