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OpenTrials
Completed

NCT Number: NCT03988153

Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Fecal Characteristics

    Time frame: 12 weeks

    Intervention with PMF to check the change in fecal weight (mg)

  2. Intestinal microflora

    Time frame: 12 weeks

    Intervention with PMF to check the change in fecal Lactobacillus spp content (1 mg)

Secondary outcomes

  1. Lipid profile

    Time frame: 12 weeks

    Intervention with PMF to check the changes in total cholesterol (mg/dl)

  2. Lag time of LDL oxidation

    Time frame: 12 weeks (5 min incubation)

    Intervention with PMF to check the LDL oxidation time (minutes)

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2019
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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