Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation

Örebro University, Sweden

Status: Completed

Conditions: Inflammation

Treatments: Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04126330

Provita19

Details and patient eligibility

About

Study objectives:

Immunity, Inflammation, and Brain Function To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on the inflammatory marker highly sensitive CRP (primary outcome), markers of inflammation (secondary outcome), and gastrointestinal barrier function (secondary outcome) in elderly and obese cohorts that exhibit elevated inflammation at baseline.

Mobility To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on joints, bones, and muscles by means of the WOMAC questionnaire, sit/stand test (muscle function) and CTX-I (cartilage degradation) as secondary endpoints in elderly and obese cohorts that exhibit elevated inflammation at baseline.

Enrollment: 176 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65-80 years old for elderly arms
• 25-65 years old for obese arms
• screening hs-CRP of 1.5-6 mg/L for elderly
• screening hs-CRP of 2-10 mg/L for obese
• BMI 18.5-27 for elderly
• BMI 28-40 for obese
• Signed informed consent prior to any study related procedures
• Prospect to start the study the latest 6 weeks after the screening visit although preferably as soon as they receive the screening results
• Willing to abstain from regular consumption of probiotic supplements, products containing probiotic bacteria
• Willing to abstain from regular consumption of medication known to alter gastrointestinal functions for at least 4 weeks prior to the time of the study inclusion
• Willing to fast at least 5 hours during the sugar-permeability-test and receive a standardised breakfast (e.g. Cereal bar) or other standardised meal
• Accepting to drink at least 1.5 litres of provided water in one day, during the two time points where the sugar test is performed

Exclusion criteria

1. Diagnosis of type 1 and/or type 2 diabetes
2. Current or within 4 weeks use of probiotic supplement prior to inclusion
3. More than 4 hours/week exercise habits
4. Immobile, defined as the inability to participate in all study related procedures
5. Dietary intake of fatty fish, fish oils containing omega-3 or pure omega- 3 supplements more than 2 times/week
6. History of complicated gastrointestinal surgery
7. Diagnosed Inflammatory Bowel Disease (IBD)
8. Current diagnosis of psychiatric disease/s or syndromes
9. Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion time
10. Use of any NSAID (Non-Steroidal Anti-Inflammatory Drugs) more than 3 times a week for the last 2 months and any time 3 days prior inclusion or at any time 3 days prior the barrier function test
11. Consumption of any NSAID up until 7 days prior to inclusion
12. Any condition which could interfere with the intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) as decided by the principal investigators´ discretion
13. Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion.
14. Regular smoking, use of snuff, nicotine or e-cigarette use
15. Regular use, for more than three times a week for the last 2 months and any time 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (e.g. laxatives, anti-diarrheal, anti-cholinergic).
16. Any disorder which according to the principal investigator can have an anti-inflammatory effect and/or can affect the intestinal barrier function, or that can impact an adequate analysis of the study outcomes
17. After being included in the study, starting with a medication/treatment or medical intervention that could potentially influence the study participation and/or the study analysis (e.g. the event of a fracture)
18. Radical change in diet (e.g. becoming vegetarian or if they discover that they are lactose intolerant) during the study period
19. Allergic to fish
20. Allergic to milk- or soy protein

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 4 patient groups, including a placebo group

Probiotics and Omega-3/vitamin D Supplements- Elderly

Experimental group

Treatment:

Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement

Placebo- Elderly

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Probiotics and Omega-3/vitamin D Supplements- Obese

Experimental group

Treatment:

Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement

Placebo- Obese

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo