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Trial record 1 of 1 for:    NCT04126330
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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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ClinicalTrials.gov Identifier: NCT04126330
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
University of Hohenheim
Pfizer
Information provided by (Responsible Party):
Robert Brummer, Örebro University, Sweden

Tracking Information
First Submitted Date  ICMJE October 11, 2019
First Posted Date  ICMJE October 15, 2019
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE September 11, 2019
Estimated Primary Completion Date April 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
proof-of-concept, randomized double-blinded placebo-controlled parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Inflammation
Intervention  ICMJE
  • Dietary Supplement: Probiotic, Omega-3, Vitamin D 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).

  • Dietary Supplement: Placebo
    Placebo generated for probiotic and omega-3/vitamin D supplements
Study Arms  ICMJE
  • Experimental: Probiotics and Omega-3/vitamin D Supplements- Elderly
    Intervention: Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement
  • Placebo Comparator: Placebo- Elderly
    Intervention: Dietary Supplement: Placebo
  • Experimental: Probiotics and Omega-3/vitamin D Supplements- Obese
    Intervention: Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement
  • Placebo Comparator: Placebo- Obese
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2019)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 13, 2020
Estimated Primary Completion Date April 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashley N Hutchinson, PhD 46737455302 ashley.hutchinson@oru.se
Contact: Lina Tingö, PhD 46735 61 17 16 lina.tingo@oru.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04126330
Other Study ID Numbers  ICMJE Provita19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Brummer, Örebro University, Sweden
Study Sponsor  ICMJE Örebro University, Sweden
Collaborators  ICMJE
  • University of Hohenheim
  • Pfizer
Investigators  ICMJE
Principal Investigator: Robert JM Brummer, Prof MD PhD Örebro University, Sweden
PRS Account Örebro University, Sweden
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP