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Intestinal Health and Blood Lipid Adjustment

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ClinicalTrials.gov Identifier: NCT02116101
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Bright Dairy & Food Co., Ltd

Brief Summary:

This was a randomized, double-blind, single-center, placebo-controlled, two-arm study. The objectives of this study were to evaluate the effect of Momchilovtsi yogurt on:

  1. Improving intestinal digestion and bowl movement;
  2. Adjusting blood total Cholesterol and Triglycerides levels;
  3. Adjusting microbiological flora (Clostridium perfringens bacteria, Lactobacillus and Bifidobacterium) in gastrointestinal tract;
  4. Adjusting short chain fatty acids (acetic acid, propionic acid, butyric acid) in in gastrointestinal tract.

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Bright Momchilovtsi Yogurt Dietary Supplement: Bright Dairy Beverage Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Momchilovtsi Yogurt on Intestinal Health and Blood Lipid Adjustment in Human Subjects
Study Start Date : March 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Active Comparator: Bright Momchilovtsi yogurt
Bright Momchilovtsi yogurt Contains 1×106cfu/g prebiotics including Lactobacillus bulgaricus and Streptococcus thermophilus
Dietary Supplement: Bright Momchilovtsi Yogurt

Oral consumption of Bright Momchilovtis Yogurt containing 1×106cfu/g prebiotics including Lactobacillus bulgaricus and Streptococcus thermophilus

Dosage: 110g at a time, twice per day at 10 am and 4 pm. Duration: 7 weeks (March 10, 2013 - April 27, 2013) The active study product has similar package and taste as the placebo.


Placebo Comparator: Bright Dairy Beverage
Dairy beverage product without prebiotics
Dietary Supplement: Bright Dairy Beverage
Oral consumption of Bright Dairy Beverage Dosage: 110g at a time, twice per day at 10 am and 4 pm. Duration: 7 weeks (March 10, 2013 - April 27, 2013) The active study product has similar package and taste as the placebo.




Primary Outcome Measures :
  1. Change from baseline in health status of the intestinal tract at Day 49 [ Time Frame: Day 0, 49 ]

    Weekly stool frequency (>6; 4-6; 1-3; 0)

    Ratio of unopened defecation times vs. total defecation times (0; 1/4; 1/3; ≥1/2)

    Duration of defecation (<5 min; 5-15 min; 16-30 min; ≥30 min)

    Defecation condition (normal perception; straining/uncomfortableness at stool; obvious straining/uncomfortableness or difficulty at stool, little feces quantity; frequent symptom of celialgia or calor at anus, which affect defecation)



Secondary Outcome Measures :
  1. Blood total cholesterol level (mmol/L) [ Time Frame: Baseline (day 0), day 49 ]
  2. Blood triglycerides level (mmol/L) [ Time Frame: Baseline (day 0), day 49 ]
  3. Fecal bacterium counts [ Time Frame: Baseline (day 0), day 49 ]
    Fecal bacterium including Clostridium perfringens bacteria, Lactobacillus and Bifidobacterium

  4. Fecal short chain fatty acids (%) [ Time Frame: Baseline (day 0), day 49 ]
    Acetic acid, propionic acid, butyric acid

  5. Score of digestive system (score 0-10) [ Time Frame: Day 0, 7, 14, 21, 28, 35, 42, 49 ]
    Abdominal distention, abdominal pain, gastric distention, heavy stomach, loss of appetite, belching

  6. Satisfaction with Defecation Habit [ Time Frame: Day 0, 7, 14, 21, 28, 35, 42, 49 ]
    Satisfied / Unsatisfied on: Defecation frequency, defecation duration , stool characteristic, and defecation habit



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged 30-60 years;
  • Abnormal blood lipids level;
  • Have aperiodic or occasional gastrointestinal symptom (gastrointestinal tympanites, abnormal borborygmus, heavy feeling after meal, celiodynia, abdominal pain);
  • Slow power of intestinal tract or irregular intestinal moving (abnormal feces solidity, decreased feces quantity, e.g. defecate every 2-3 days or defecate less than 3 times a week)

Exclusion Criteria:

  • Diagnosed as chronic constipation;
  • Receiving treatment for gastrointestinal symptoms;
  • Lactose Intolerance;
  • In use of analgesic such as aspirin or Panadol, etc;
  • Have had laxatives or other substance that will enhance digestion within 2 weeks before the study begins;
  • Have had dairy products or other food containing probiotics within 10 days before the study begins;
  • Have diarrhea currently;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116101


Sponsors and Collaborators
Bright Dairy & Food Co., Ltd
Investigators
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Principal Investigator: Donglian Cai, MD Department of Nutrition, The Second Military Medical University Affilated Changhai Hospital

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Responsible Party: Bright Dairy & Food Co., Ltd
ClinicalTrials.gov Identifier: NCT02116101     History of Changes
Other Study ID Numbers: 12-SC-11-BRD-001
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Keywords provided by Bright Dairy & Food Co., Ltd:
Intestinal Health
Prebiotics
Blood Lipid
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms