A Phase 1 interventional study of Probiotic Milk Formula in Healthy, sponsored by Chung Shan Medical University. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by Chung Shan Medical University · Phase 1, Interventional, and Treatment
Probiotic contained milk formula (PMF) intervention for 10 weeks considerably improves gastrointestinal function by modulating fecal movement, intestinal microflora as well as decrease cholesterol and thus help in the management of hypercholesterolemia.
Current randomized placebo-controlled, double-blind was designed to assess the effect of probiotic contained milk formula (PMF) on lipid profile and intestinal function in healthy mild hypercholesterolemic subjects. Totally forty healthy mild hypercholesterolemic subjects (180-220 mg/dL) were randomly chosen and divided into two groups as placebo or experimental group. All the subjects were requested to drink either PMF (experimental) or skimmed milk drink formula-Placebo (30 gm mixed with 200 mL of water) for 10 weeks and continued by 2 weeks of the follow-up period. Supplementation of PMF for 10 weeks significantly improved (p\< 0.05) the fecal weight, fecal movement (decreased fecal GI passing time) by improving intestinal microflora (increasing beneficial bacterial species like Lactobacillus, Bifidobacterium spp) and Lag time of LDL oxidation. In addition, intake of PMF substantially reduced (p\< 0.05) the levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) and thus showcasing its cardioprotective efficacy. Therefore PMF is recommended for the management of hypercholesterolemia.
Chung Shan Medical University is the lead sponsor of 125 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Twenty subjects should drink 200 mL of PMF (30 gm mixed with 200 mL of water) before breakfast and dinner (2 times/day) for 10 weeks
Combination Product: Probiotic Milk Formula
Twenty subjects should drink 200 mL of skimmed milk drink (30 gm mixed with 200 mL of water) before breakfast and dinner (2 times/day) for 10 weeks
Combination Product: Probiotic Milk Formula
Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect
Fecal Characteristics
Intervention with PMF to check the change in fecal weight (mg)
Time frame: 12 weeks
Intestinal microflora
Intervention with PMF to check the change in fecal Lactobacillus spp content (1 mg)
Time frame: 12 weeks
Lipid profile
Intervention with PMF to check the changes in total cholesterol (mg/dl)
Time frame: 12 weeks
Lag time of LDL oxidation
Intervention with PMF to check the LDL oxidation time (minutes)
Time frame: 12 weeks (5 min incubation)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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