InflammationNCT04126330
Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation
A study testing Probiotic, Omega-3, Vitamin D supplement in people with Inflammation, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Inflammation
- What is being tested?
- Probiotic, Omega-3, Vitamin D supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteSweden
- Study dates
- 11 Sep 2019to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
- Conditions
- Inflammation
- Being tested
- Probiotic, Omega-3, Vitamin D supplement, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic, Omega-3, Vitamin D supplementDietary supplement
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).
PlaceboDietary supplement
Placebo generated for probiotic and omega-3/vitamin D supplements
| Study group | Role | What they receive |
|---|---|---|
| Probiotics and Omega-3/vitamin D Supplements- Elderly | Experimental | Not described Receives: Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement |
| Placebo- Elderly | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Probiotics and Omega-3/vitamin D Supplements- Obese | Experimental | Not described Receives: Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement |
| Placebo- Obese | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP
Decrease in overall body inflammation measured by at least 15% reduction in hs-CRP levels in blood
Measured: baseline, 4 weeks (mid-study), 8 weeks (study end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start11 Sep 2019
- Primary completion15 May 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- proof-of-concept, randomized double-blinded placebo-controlled parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hohenheim, Pfizer
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert JM Brummer, Prof MD PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126330
- Sponsor's protocol ID
- Provita19
- Status last verified
- Feb 2021
- First submitted
- 11 Oct 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04126330
- Acronym / sponsor ID
- Provita19
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- University of Hohenheim, Pfizer
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- proof-of-concept, randomized double-blinded placebo-controlled parallel study
| Arm | Type | Receives |
|---|---|---|
| Probiotics and Omega-3/vitamin D Supplements- Elderly | Experimental | Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement |
| Placebo- Elderly | Placebo comparator | Dietary Supplement: Placebo |
| Probiotics and Omega-3/vitamin D Supplements- Obese | Experimental | Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement |
| Placebo- Obese | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic, Omega-3, Vitamin D supplementThe 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). | Dietary supplement | Probiotics and Omega-3/vitamin D Supplements- Elderly, Probiotics and Omega-3/vitamin D Supplements- Obese |
| PlaceboPlacebo generated for probiotic and omega-3/vitamin D supplements | Dietary supplement | Placebo- Elderly, Placebo- Obese |
Primary outcome
hs-CRP
Time frame: baseline, 4 weeks (mid-study), 8 weeks (study end)
Decrease in overall body inflammation measured by at least 15% reduction in hs-CRP levels in blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert JM Brummer, Prof MD PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic, Omega-3, Vitamin D supplement in people with Inflammation, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hs-CRP (time frame: baseline, 4 weeks (mid-study), 8 weeks (study end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.