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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-11
• Primary completion: 2020-05-15
• Completion: 2020-12-15
• First posted: 2019-10-15
• Last updated: 2021-02-24

Locations

1 site across 1 country: Sweden