Status:
COMPLETED
Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation
Lead Sponsor:
Örebro University, Sweden
Collaborating Sponsors:
University of Hohenheim
Pfizer
Conditions:
Inflammation
Eligibility:
All Genders
25-80 years
Phase:
NA
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 out...
Eligibility Criteria
Inclusion
- 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
- Diagnosis of type 1 and/or type 2 diabetes
- Current or within 4 weeks use of probiotic supplement prior to inclusion
- More than 4 hours/week exercise habits
- Immobile, defined as the inability to participate in all study related procedures
- Dietary intake of fatty fish, fish oils containing omega-3 or pure omega- 3 supplements more than 2 times/week
- History of complicated gastrointestinal surgery
- Diagnosed Inflammatory Bowel Disease (IBD)
- Current diagnosis of psychiatric disease/s or syndromes
- Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion time
- 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
- Consumption of any NSAID up until 7 days prior to inclusion
- 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
- Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion.
- Regular smoking, use of snuff, nicotine or e-cigarette use
- 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).
- 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
- 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)
- Radical change in diet (e.g. becoming vegetarian or if they discover that they are lactose intolerant) during the study period
- Allergic to fish
- Allergic to milk- or soy protein
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04126330
Start Date
September 11 2019
End Date
December 15 2020
Last Update
February 24 2021
Active Locations (1)
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1
Örebo University
Örebro, Sweden, 703 62