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出境医 / 临床实验 / Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Combination Product: Probiotic Milk Formula Phase 1

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, randomized parallel clinical trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function in Mild Hypercholesterolemic Volunteers: A Placebo-control, Randomized Clinical Trial
Actual Study Start Date : November 10, 2010
Actual Primary Completion Date : March 15, 2011
Actual Study Completion Date : April 20, 2011
Arms and Interventions
Arm Intervention/treatment
Experimental: Probiotic Milk Formula (PMF)
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
Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect
Placebo Comparator: Skimmed 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
 Combination Product: Probiotic Milk Formula
Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE November 10, 2010
Actual Primary Completion Date March 15, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Fecal Characteristics [ Time Frame: 12 weeks ]
    Intervention with PMF to check the change in fecal weight (mg)
  • Intestinal microflora [ Time Frame: 12 weeks ]
    Intervention with PMF to check the change in fecal Lactobacillus spp content (1 mg)
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Fecal Characteristics [ Time Frame: 12 weeks ]
    fecal weight: increased (200-300 gm)
  • Intestinal microflora [ Time Frame: 12 weeks ]
    Lactobacillus spp increased (1 mg)
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Lipid profile [ Time Frame: 12 weeks ]
    Intervention with PMF to check the changes in total cholesterol (mg/dl)
  • Lag time of LDL oxidation [ Time Frame: 12 weeks (5 min incubation) ]
    Intervention with PMF to check the LDL oxidation time (minutes)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Lipid profile [ Time Frame: 12 weeks ]
    total cholesterol-decrease by 8% (156 mg/dl)
  • Lag time of LDL oxidation [ Time Frame: 12 weeks (5 min incubation) ]
    LDL oxidation time reduced
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function
Official Title  ICMJE Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function in Mild Hypercholesterolemic Volunteers: A Placebo-control, Randomized Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, placebo-controlled, randomized parallel clinical trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Combination Product: Probiotic 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 Arms  ICMJE
  • Experimental: Probiotic Milk Formula (PMF)
    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
    Intervention: Combination Product: Probiotic Milk Formula
  • Placebo Comparator: Skimmed 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
    Intervention: Combination Product: Probiotic Milk Formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2019) 		40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 20, 2011
Actual Primary Completion Date March 15, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988153
Other Study ID Numbers  ICMJE CS08006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chin Kun Wang, Chung Shan Medical University
Study Sponsor  ICMJE Chung Shan Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chung Shan Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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