Clinical trial NCT04126330: Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation
Official title: Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation: Targeting Inflammation and Intestinal Barrier Function in the Elderly and Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: University of Hohenheim
name: Pfizer
First posted: 2019-10-15
Enrollment: 176
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: proof-of-concept, randomized double-blinded placebo-controlled parallel study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: hs-CRP
timeFrame: baseline, 4 weeks (mid-study), 8 weeks (study end)
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebo University
Study officials:
affiliation: Örebro University, Sweden
name: Robert JM Brummer, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References: