Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic, Omega-3, Vitamin D supplement
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Inflammation
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:
- 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
Sites / Locations
- Örebo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Probiotics and Omega-3/vitamin D Supplements- Elderly
Placebo- Elderly
Probiotics and Omega-3/vitamin D Supplements- Obese
Placebo- Obese
Arm Description
Outcomes
Primary Outcome Measures
hs-CRP
Decrease in overall body inflammation measured by at least 15% reduction in hs-CRP levels in blood
Secondary Outcome Measures
Full Information
NCT ID
NCT04126330
First Posted
October 11, 2019
Last Updated
February 23, 2021
Sponsor
Örebro University, Sweden
Collaborators
University of Hohenheim, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT04126330
Brief 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
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
Collaborators
University of Hohenheim, Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
proof-of-concept, randomized double-blinded placebo-controlled parallel study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics and Omega-3/vitamin D Supplements- Elderly
Arm Type
Experimental
Arm Title
Placebo- Elderly
Arm Type
Placebo Comparator
Arm Title
Probiotics and Omega-3/vitamin D Supplements- Obese
Arm Type
Experimental
Arm Title
Placebo- Obese
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic, Omega-3, Vitamin D supplement
Intervention Description
The first supplement we would like to assess is named VNP and is composed by Omega-3 Active and vitamin D. It contains a total of 1100 mg fish oils: 640 mg Omega-3 and with 300 mg eicosapentaenoic acid (EPA), 220 mg docosahexaenoic acid (DHA) plus 200 IU Vitamin D per daily dose (2 capsules).
The second supplement we investigate is four-strain probiotics combination based on the commercially available formulation HOWARU® by DuPont; two capsules containing 10 billion CFU total (supplied by Pfizer but manufactured by Danisco, DuPont). The probiotic specific composition, contains equal amounts of each strain per capsule (1.25 x 109 CFU each): Bifidobacterium lactis Bi-07, Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04. One capsule contains 5 billion CFU (Swedish milliards).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo generated for probiotic and omega-3/vitamin D supplements
Primary Outcome Measure Information:
Title
hs-CRP
Description
Decrease in overall body inflammation measured by at least 15% reduction in hs-CRP levels in blood
Time Frame
baseline, 4 weeks (mid-study), 8 weeks (study end)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert JM Brummer, Prof MD PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebo University
City
Örebro
ZIP/Postal Code
703 62
Country
Sweden
12. IPD Sharing Statement
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Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation
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