The study is a randomized, double-blind, 3-arm, placebo-controlled pilot study in an elderly population (60-85 years) with low-grade inflammation (hs-CRP 2-10 mg/L) comparing two doses daily intake of Bif-038 at 1 and 10 billion CFU to placebo for 12 weeks. The subjects will receive either one of the two test products or the placebo product daily for a period of 12 weeks.~During the entire study period, five visits are scheduled. The subjects will participate in two screening visits; a baseline visit, a visit after 6 weeks of intervention and an end-of-study visit after 12 weeks of intervention. Visit 1 and 2 are screening- and recruitment visits with at least two weeks apart. Only participants with a hs-CRP within 2.0-10.0 mg/L will be invited for the second screening visit. Participants with repeated hs-CRP levels within 2.0-10.0 mg/L will be invited for baseline visit 3, to be included and randomized in the study.~At the screening visits the eligibility will be checked after the participants have given their written informed consent.~Blood samples and stool samples will be collected during the study and subjects will be asked to complete questionnaires and a dietary diary.~No sample size calculations were performed due to the exploratory nature of a pilot study design. Planned number to include is 20 subjects per study arm, thus 60 subjects in total.
To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population