Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

NCT03988153 | Completed Phase 1 DMC

• 1 other identifier: CS08006
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Lipid profile

  12 weeks

• Lag time of LDL oxidation

  12 weeks (5 min incubation)

Study Arms (2)

Probiotic Milk Formula (PMF)

EXPERIMENTAL

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

Skimmed Milk Formula

PLACEBO COMPARATOR

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

Interventions

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

Probiotic Milk Formula (PMF); Skimmed Milk Formula

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy mild hypercholesterolemic subjects (180-220 mg/dL)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind, placebo-controlled, randomized parallel clinical trial

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: November 10, 2010
• Primary Completion: March 15, 2011
• Study Completion: April 20, 2011
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share