Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

Chung Shan Medical University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Combination Product: Probiotic Milk Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT03988153

CS08006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Probiotic Milk Formula (PMF)

Experimental group

Description:

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

Treatment:

Combination Product: Probiotic Milk Formula

Skimmed Milk Formula

Placebo Comparator group

Description:

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

Treatment:

Combination Product: Probiotic Milk Formula