Intestinal Health and Blood Lipid Adjustment
Intestinal Health and Blood Lipid Adjustment
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.
1. Quality control of the study:

 1.1 Study monitoring and source data verification:

 Monitoring was done according to the monitoring plan by a representative of the
 investigator, who checked the case report forms for completeness and clarity, and
 cross-checked them with source documents. In addition to the monitoring visits, frequent
 communications (letter, telephone, fax, e-mail), by the study monitor ensured that the
 investigation was conducted according to protocol design and regulatory requirements.
 Study close-out was performed by the study monitor upon closure of the study.

 1.2 On-site audits:

 Domestic and foreign regulatory authorities, the Institutional Review Board, and an
 auditor authorized by the sponsor may request access to all source documents, case
 report forms, and other study documentation for on-site audit or inspection. Direct
 access to these documents was guaranteed by the investigator, who must provide support
 at all times for these activities. Medical records and other study documents may be
 copied during audit or inspection provided that subject names are obliterated on the
 copies to ensure confidentiality.

 1.3 Documentation:

 A case report form was provided for each subject.

 All protocol-required information collected during the study was entered by the
 investigator, or designated representative, in the case report form. Details of case
 report form completion and correction were explained to the investigator.

 The investigator, or designated representative, should complete the case report form
 pages as soon as possible after information is collected, preferably on the same day
 that a study patient is seen for an examination, treatment, or any other study
 procedure. Any outstanding entries must be completed immediately after the final
 examination. An explanation should be given for all missing data.

 A source data location list was prepared prior to study initiation. This list was filed
 in both the trial master file and the investigator study file and updated as necessary.

 The completed case report forms were reviewed and signed by the investigator named in
 the clinical study protocol or by a designated sub investigator.

 The sponsor would retain the original of all completed case report forms. The principal
 investigator kept the copies of all completed case report forms for 25 years after the
 trial based on Good Clinical Practice requirements.

 2. Quality assurance of study products:

 All products used in this study were manufactured and provided by Bright Dairy & Food
 Co., Ltd. The quality test of study products was conducted by Shanghai dairy products
 quality supervision and inspection station. The study products were stored at the study
 site and assigned to the subjects by the investigator. The amount of products received
 and assigned were filed on product distribution list by the investigator. The study
 products were not allowed to be given to anyone who didn't participated in the study. No
 sales of unassigned products was allowed. After the completion of the study, the
 unassigned products need to be returned to Bright Dairy & Food Co., Ltd.

 The products were labeled with study code. A master participation list was completed
 which identifies each patient full name and unique identification number. The identity
 of the specific product was blind to patients, support staff and investigators. The
 unmasking occurred to the investigators and statistical analyses team only after
 completion of statistical analyses.

 3. Data management:

 Study data were recorded on Case Report Forms (CRFs) and then entered into saved in the
 form of Excel files. Data was double entered and cross-validated.

 4. Management of subject withdrawal:

 A number of 120 subjects were enrolled in the study.

 Subjects may be withdrawn from the study for the following reasons:

 -  At their own request or at the request of their legally authorized representative,

 -  If, in the investigator's opinion, continuation in the study would be detrimental
 to the patient's well-being,

 -  If they are lost to follow-up.

 In all cases, the reason for and date of withdrawal must be recorded in the Exit Form
 and in the subject's medical records and the sponsor's representative must be notified
 within 5 days. The subject must be followed up to establish whether the reason was an
 adverse event, and, if so, this must be reported in accordance with the procedure of an
 adverse event (described bellow). The investigator must make every effort to contact
 subject lost to follow-up. Attempts to contact such subject must be documented in the
 subject's records (e.g., dates and times of attempted telephone contact).

 Investigator must be notified of all serious or unexpected adverse events within 48
 hours. Notification does not depend on whether there is a connection to the study
 formula or not. All adverse events must be documented on the appropriate pages of the
 case report forms.

 5. Statistical analysis plan:

 Analysis was performed for the intent-to-treat population.

 Chi-square test was used comparison between study groups for categorical data. For continuous
 outcomes, t-test was used for between-group comparison, paired t-test was used for pre-post
 comparison within each study group.3. Non-parametric methods were used for non-normal data,
 data with unequal variances. The analysis was completed using the statistical package
 SPSS17.0.
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;