Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

Phase 1

Completed

• Conditions: Healthy
• Interventions: Combination Product: Probiotic Milk Formula

• Registration Number: NCT03988153
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11-10
• Primary Completion: 2011-03-15
• Study Completion: 2011-04-20
• Status Verified: 2019-06
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-14
• Last Update Submitted: 2019-06-14
• Study First Posted: 2019-06-17
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skimmed Milk Formula	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
Probiotic Milk Formula (PMF)	Probiotic Milk Formula	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

Primary Outcome Measures

Name	Time	Method
Fecal Characteristics	12 weeks	Intervention with PMF to check the change in fecal weight (mg)
Intestinal microflora	12 weeks	Intervention with PMF to check the change in fecal Lactobacillus spp content (1 mg)

Secondary Outcome Measures

Name	Time	Method
Lipid profile	12 weeks	Intervention with PMF to check the changes in total cholesterol (mg/dl)
Lag time of LDL oxidation	12 weeks (5 min incubation)	Intervention with PMF to check the LDL oxidation time (minutes)