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

Sponsor

Örebro University, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT04126330

Collaborator

University of Hohenheim (Other), Pfizer (Industry)

176

Enrollment

Location

Arms

15.1

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation	Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

proof-of-concept, randomized double-blinded placebo-controlled parallel studyproof-of-concept, randomized double-blinded placebo-controlled parallel study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 11, 2019

Actual Primary Completion Date :

May 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotics and Omega-3/vitamin D Supplements- Elderly	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).
Placebo Comparator: Placebo- Elderly	Dietary Supplement: Placebo Placebo generated for probiotic and omega-3/vitamin D supplements
Experimental: Probiotics and Omega-3/vitamin D Supplements- Obese	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).
Placebo Comparator: Placebo- Obese	Dietary Supplement: Placebo Placebo generated for probiotic and omega-3/vitamin D supplements

Outcome Measures

Primary Outcome Measures

hs-CRP [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Örebo University	Örebro		Sweden	703 62

Sponsors and Collaborators

Örebro University, Sweden
University of Hohenheim
Pfizer

Investigators

Principal Investigator: Robert JM Brummer, Prof MD PhD, Örebro University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Brummer, Professor of Gastroenterology and Clinical Nutrition, Director Nutrition-Gut-Brain Interactions Research Centre, Örebro University, Sweden

ClinicalTrials.gov Identifier:

NCT04126330

Other Study ID Numbers:

Provita19

First Posted:

Oct 15, 2019

Last Update Posted:

Feb 24, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Vitamin D

Study Results

No Results Posted as of Feb 24, 2021