Intestinal Health and Blood Lipid Adjustment

NCT02116101 | Completed DMC

• 1 other identifier: 12-SC-11-BRD-001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Constipation

Keywords

Intestinal Health; Prebiotics; Blood Lipid

Outcome Measures

Primary Outcomes (1)

• Change from baseline in health status of the intestinal tract at Day 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)

  Day 0, 49

Secondary Outcomes (6)

• Blood total cholesterol level (mmol/L)

  Baseline (day 0), day 49

• Blood triglycerides level (mmol/L)

  Baseline (day 0), day 49

• Fecal bacterium counts

  Baseline (day 0), day 49

• Fecal short chain fatty acids (%)

  Baseline (day 0), day 49

• Score of digestive system (score 0-10)

  Day 0, 7, 14, 21, 28, 35, 42, 49

Study Arms (2)

Bright Momchilovtsi yogurt

ACTIVE COMPARATOR

Bright Momchilovtsi yogurt Contains 1×106cfu/g prebiotics including Lactobacillus bulgaricus and Streptococcus thermophilus

Dietary Supplement: Bright Momchilovtsi Yogurt

Bright Dairy Beverage

PLACEBO COMPARATOR

Dairy beverage product without prebiotics

Dietary Supplement: Bright Dairy Beverage

Interventions

Bright Momchilovtsi Yogurt DIETARY_SUPPLEMENT

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.

Bright Momchilovtsi yogurt

Bright Dairy Beverage DIETARY_SUPPLEMENT

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.

Bright Dairy Beverage

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bright Dairy & Food Co., Ltd: lead

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donglian Cai, MD

  Department of Nutrition, The Second Military Medical University Affilated Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2014
• First Posted: April 16, 2014
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 16, 2014

Record last verified: 2014-04