Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-24 @ 1:27 PM
NCT ID:
NCT03060395
Eligibility Criteria:
Inclusion Criteria:
* BMI: 20-35kg/m2
* Glucose\<7mmol/l (not diagnosed with diabetes)
* Total cholesterol\<7mmol/l
* Triacylglycerol\<4mmol/l
* Normal liver and kidney function
* Regular milk drinker with self-reported intolerance to commercial milk.
* Suffered from mild to moderate digestive discomfort after milk consumption.
* Have normal blood pressure 120/80 mmHg (BP \<160/90 mmHg can be accepted) during quiet respiration.
* Agree not to take any medication, supplements and 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 enrol 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:
* Females who are pregnant or planning to be a pregnant and lactating.
* Have known dairy allergy.
* Have stopped drinking milk for the last 6 month.
* Have history of lactose intolerance
* Have history of faecal impaction.
* Received antibiotics in the previous six months
* Smoker
* Anemia
* 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.
* History of alcohol or drug misuse.
* 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, cardiovascular diseases and known on-going allergy such as asthma.
* Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including 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.
* Who take medication at least the last 6-month.
* Who do excessive exercise not as part of a weight-loss regime, e.g. athletes.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
56 Years
Study:
NCT03060395
Study Brief:
Protocol Section:
NCT03060395