An Early Phase 1 interventional study of Probiotic drink and Control Group in Aged and Healthy, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to male participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-28.
Sponsored by Charite University, Berlin, Germany · Early Phase 1, Interventional, and Prevention
Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.
Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Intervention trial:
Exclusion Criteria:
without intervention
Other: Control Group
This group receives a probiotic drink daily for 6 week.
Dietary Supplement: Probiotic drink
This group receives a probiotic drink daily for 6 week.
without intervention
Pre/post-intervention change in hsCRP
Change (reduction) of hsCRP over a 6-week period in older persons.
Time frame: 6 weeks
Intestinal permeability
Intestinal permeability tests will be performed with a triple sugar test (5 g LAC, 10 g MAN, and 20 g SAC dissolved in 100 ml of water).
Time frame: 6 weeks
Stool: Stool: Real-Time-PCR
During screening and post intervention quantitative Real-Time-PCR of bacterial 16S ribosomal RNA from feces will be performed.
Time frame: 6 weeks
Blood screening
Day 0 - Screening: hsCRP, leukocytes, erythrocytes, haemoglobin, haematokrit, sodium, potassium, glucose, total cholesterol, HDL, LDL, bilirubin total, bilirubin direct, ASAT, ALAT, creatinine Day 42 - post intervention: hsCRP, leukocytes, erythrocytes, haemoglobin, haematokrit, glucose, total cholesterol, HDL, LDL.
Time frame: 6 weeks
Muscle function
Handgrip strength will be evaluated using the Jamar vigorimeter (Preston, Jackson, MI 49204, USA) on Day 0 in the screening period and at the end of the intervention trial.
Time frame: 6 weeks
Physical performance status
The short physical performance battery (SPPB) (24) will be performed at the start and at the end of the intervention trial. SPPB is used to assess lower extremity function. It evaluates balance, gait, strength, and endurance.
Time frame: 6 weeks
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany