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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
176
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 generated for probiotic and omega-3/vitamin D supplements
Örebo University
Örebro, Sweden
hs-CRP
Decrease in overall body inflammation measured by at least 15% reduction in hs-CRP levels in blood
Time frame: baseline, 4 weeks (mid-study), 8 weeks (study end)
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