NCT04126330

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

Completed NA Last updated 24 February 2021

What this trial tests

NA trial testing Probiotic, Omega-3, Vitamin D supplement in Inflammation in 176 participants. Completed in 15 December 2020.

Timeline

11 September 2019

Primary endpoint
15 May 2020

15 December 2020

Quick facts

Lead sponsor	Örebro University, Sweden
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	176
Start date	11 September 2019
Primary completion	15 May 2020
Estimated completion	15 December 2020
Sites	1 location across Sweden

Drugs / interventions tested

• Probiotic, Omega-3, Vitamin D supplement
• Placebo

Conditions studied

• Inflammation — all drugs for Inflammation →

Sponsor

Örebro University, Sweden

Who can join

Adults 25 to 80, any sex, with Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential Modulation of Inflammation and Physical Function by Combined Probiotics, Omega-3 Supplementation and Vitamin D Supplementation in Overweight/Obese Patients with Chronic Low-Grade Inflammation: A Randomized, Placebo-Controlled Trial.
   Kopp L, Schweinlin A, Tingö L, Hutchinson AN, et al · · 2023 · cited 16× · PMID 37239916 · DOI 10.3390/ijms24108567
2. Potential Modulation of Inflammation by Probiotic and Omega-3 Supplementation in Elderly with Chronic Low-Grade Inflammation-A Randomized, Placebo-Controlled Trial.
   Tingö L, Hutchinson AN, Bergh C, Stiefvatter L, et al · · 2022 · cited 14× · PMID 36235651 · DOI 10.3390/nu14193998
3. Microbial-Based Bioactive Compounds to Alleviate Inflammation in Obesity.
   Apalowo OE, Adegoye GA, Obuotor TM. · · 2024 · cited 9× · PMID 38534735 · DOI 10.3390/cimb46030119