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Comparison of milk containing A1A2 beta casein and milk containing A2A2 beta casein among students of the Faculty of Public Health, Universitas Indonesia

Comparison of milk containing A1A2 beta casein and milk containing A2A2 beta casein to the symptoms of post dairy digestive discomfort and milk-specific IgE among students of the Faculty of Public Health, Universitas Indonesia Depok (a double-blind randomized two-way cross-over study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48062365
Enrollment
60
Registered
2018-06-25
Start date
2017-10-20
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-diary digestive discomfort Signs and Symptoms

Interventions

All participants selected in this study received two interventions, that is milk containing A1A2 beta casein and milk containing A2A2 beta casein. Participants were randomized to decide who received t

Sponsors

Universitas Indonesia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. Woman in pregnancy and breastfeeding 2. Consume anti inflammatory or immunosuppressive drugs within 4 weeks before screening 3. Have an allergy

Design outcomes

Primary

MeasureTime frame
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) 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

Secondary

MeasureTime frame
Stool consistency and frequency, measured using The Bristol Stool Scale every day during the intervention. Stool consistency was rated on 7 type Likert scale: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: like a sausage or snake, smooth and soft Type 5: Soft blobs with clear-cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026