Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03988153

Enrollment

Registered

2019-06-17

Start date

2010-11-10

Completion date

2011-04-20

Last updated

2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Probiotics, cholesterol, LDL-c, Hypercholesterolemic, Fecal movement

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.

Interventions

COMBINATION_PRODUCTProbiotic Milk Formula

Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

Double-blind, placebo-controlled, randomized parallel clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026