Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation

NCT ID: NCT04126330

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2020-12-15

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotics and Omega-3/vitamin D Supplements- Elderly

Group Type: EXPERIMENTAL

Probiotic, Omega-3, Vitamin D supplement

Intervention Type: DIETARY_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).

Placebo- Elderly

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo generated for probiotic and omega-3/vitamin D supplements

Probiotics and Omega-3/vitamin D Supplements- Obese

Group Type: EXPERIMENTAL

Probiotic, Omega-3, Vitamin D supplement

Intervention Type: DIETARY_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).

Placebo- Obese

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo generated for probiotic and omega-3/vitamin D supplements

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo generated for probiotic and omega-3/vitamin D supplements

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hohenheim

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Robert Brummer

Professor of Gastroenterology and Clinical Nutrition, Director Nutrition-Gut-Brain Interactions Research Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert JM Brummer, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Örebo University

Örebro, , Sweden

Countries

Sweden

Other Identifiers

Provita19

Identifier Type: -

Identifier Source: org_study_id