Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function in Mild Hypercholesterolemic Volunteers: A Placebo-control, Randomized Clinical Trial

Conditions
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Healthy

Intervention / Treatment
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* Combination Product: Probiotic Milk Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy mild hypercholesterolemic subjects (180-220 mg/dL) Exclusion Criteria: Subjects who took antibiotics or supplements (vitamins or minerals), probiotics (especially dairy products), Subjects suffering from severe gastrointestinal, cardiovascular, hepatic or renal disorders, Lactating or pregnant women, chain smokers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, placebo-controlled, randomized parallel clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Milk Formula (PMF)<br>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<br>* Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect<br>|
| Placebo Comparator: Skimmed Milk Formula<br>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<br>* Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 12 weeks (5 min incubation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, cholesterol, LDL-c, Hypercholesterolemic, Fecal movement