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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Milk Formula (PMF) | Experimental | 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 |
|
| Skimmed Milk Formula | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Milk Formula | Combination Product | Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect |
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| Measure | Description | Time Frame |
|---|---|---|
| Fecal Characteristics | Intervention with PMF to check the change in fecal weight (mg) | 12 weeks |
| Intestinal microflora | Intervention with PMF to check the change in fecal Lactobacillus spp content (1 mg) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Intervention with PMF to check the changes in total cholesterol (mg/dl) | 12 weeks |
| Lag time of LDL oxidation | Intervention with PMF to check the LDL oxidation time (minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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Double-blind, placebo-controlled, randomized parallel clinical trial
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| 12 weeks (5 min incubation) |