Cooked or not there is enough evidence to indicate something there..but the quality of the result are iffy.
Found an alternative study (published 2 April 2016), that followed a similar methodology. You would think they would mimic the same outcome in the new study but to the larger scale.
Why did they not identify the subjects tested, or international baseline study followed?
Is this apples for apples?
1. New study info (see
https://clinicaltrials.gov/show/NCT02878876):
|
Ages Eligible for Study: |
20 Years to 50 Years (Adult) |
| 1 |
Sexes Eligible for Study: |
All |
| 2 |
Accepts Healthy Volunteers: |
Yes |
Criteria
Inclusion Criteria:
- 20~50 years old male or female subjects;
- Non-regular milk drinker with self-reported intolerance to commercial milk;
- Suffered from mild to moderate digestive discomfort after milk consumption;
- Have normal electrocardiograms (ECG) and blood pressure during quiet respiration;
- Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
- Be willing to comply with all the requirements and procedures of the study;
- Agree to sign the informed consent form;
- Agree not to enroll in another interventional clinical research study while participating in this study;
- Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
Exclusion Criteria:
- Female on pregnant or feeding；
- Have known dairy allergy;
- Have severe response to milk intolerance;
- Have history of faecal impaction;
- Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ;
- Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
- Currently taking medicines for cardiovascular or metabolic disease;
- Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
- Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs in regular frequency which may affect gastrointestinal disorders and study result;
- Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
- Had hospitalizations within 3 months before screening;
- Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.
2. Study published 2 April 2016 , see
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818854/
Study design
The study was conducted in Accordance with the Declaration of Helsinki as amended in Seoul 2008 and was approved by the ethics committee of the Shanghai Nutrition Society (approval number: SNSIRB#2014[002]). The study was registered with ClinicalTrials.gov (identifier:
NCT02406469). All subjects provided written informed consent prior to inclusion in the study.
Subjects
The inclusion criteria were as follows: male or female; age 25–68 years; irregular milk consumption (as documented using a food frequency questionnaire); self-reported intolerance to commercial milk; self-reported mild to moderate digestive discomfort after milk consumption; and normal electrocardiograms (ECG) and blood pressure during quiet respiration.
Subjects were enrolled if they: agreed not to take any medication, nutritional supplements, or other dairy products, including acidophilus milk, during the study; were willing to comply with all of the requirements and procedures; provided signed informed consent; agreed not to participate in another interventional clinical research study during the present study; did not meet any of the exclusion criteria (see Additional file
1); and fully understood the nature, objective, benefit, and the potential risks and side effects of the study. No subjects with existing conditions such as irritable bowel syndrome, constipation, or un-medicated inflammatory bowel disease were enrolled.
Subjects were recruited via advertisements placed on noticeboards at community hospitals.
(20min delay)