Comparison of milk containing A1A2 beta casein and milk containing A2A2 beta casein among students of the Faculty of Public Health, Universitas Indonesia
Completed
- Conditions
- Post-diary digestive discomfortSigns and Symptoms
- Registration Number
- ISRCTN48062365
- Lead Sponsor
- niversitas Indonesia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Students of Faculty of Public Health, Universitas Indonesia
2. Male or female, aged 17-25 years
3. Irregular milk consumption (FFQ screening)
4. Felt the symptoms of digestive discomfort after consume commercial dairy products
5. Have a normal blood pressure
6. BMI 19-27.5 kg/m2
7. Willing to follow all of the requirements and procedures of this study and agree to sign informed consent
Exclusion Criteria
1. Woman in pregnancy and breastfeeding
2. Consume anti inflammatory or immunosuppressive drugs within 4 weeks before screening
3. Have an allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Symptoms of post-diary digestive discomfort, measured by questionnaire that asked the participants how they felt after milk consumption, such as bloating, abdominal pain, flatulence, heavy stomach and borborygmi (stomach rumbling). The participants were asked to fill out each questionnaire after milk consumption (twice a day) during the intervention period. Each symptom was ranked on Likert scale, as never (score =0), rarely (score=1), moderate (score=2) and severe (score=3)<br>2. Immune response (milk-specific IgE antibodies), assessed by milk-specific IgE blood serum test. Blood serum sample was performed by the laboratory assistant as follows: blood samples were taken within a range of 12 hours before starting the intervention and after the intervention; laboratory assistant takes 5 ml of venous blood; samples were analyzed by ELISA (enzyme-linked immunosorbent assay) technique in the laboratory<br>
- Secondary Outcome Measures
Name Time Method Stool consistency and frequency, measured using The Bristol Stool Scale every day during the intervention. Stool consistency was rated on 7 type Likert scale:<br>Type 1: Separate hard lumps, like nuts (hard to pass)<br>Type 2: Sausage-shaped but lumpy<br>Type 3: Like a sausage but with cracks on its surface<br>Type 4: like a sausage or snake, smooth and soft<br>Type 5: Soft blobs with clear-cut edges (passed easily)<br>Type 6: Fluffy pieces with ragged edges, a mushy stool<br>Type 7: Watery, no solid pieces, entirely liquid