Comparison of milk containing A1A2 beta casein and milk containing A2A2 beta casein among students of the Faculty of Public Health, Universitas Indonesia
| ISRCTN | ISRCTN48062365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48062365 |
| Secondary identifying numbers | No.021/SP/AKD/2017 |
- Submission date
- 24/05/2018
- Registration date
- 25/06/2018
- Last edited
- 29/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
The symptoms of digestive discomfort after consuming dairy products are the main reasons for somebody to avoid commercial dairy products. Most suspect that post-dairy digestive discomfort is caused by lactose intolerance, but in fact some cases are because of a reaction to several types of milk proteins. Cow's milk contains two types of beta casein, A1 beta casein and A2 beta casein. The A1 beta casein type commonly found in commercial milk is broken down into beta-casomorphin-7 (BCM-7) in the digestive system and causes digestive discomfort. In contrast to A1 beta casein type, A2 beta casein type does not produce BCM-7 so it does not show similar symptoms. The aim of this study is to compare the effects of milk with different types of beta casein - i.e. milk containing beta casein combination A1 type and A2 type (A1A2 beta casein) and milk containing only A2 beta casein type (A2A2 beta casein) - on the symptoms of post-dairy digestive discomfort, stool frequency and consistency and also immune response.
Who can participate?
Undergraduate students of Faculty of Public Health, Universitas Indonesia, aged 17-25, who have symptoms of digestive discomfort after consuming dairy or cow’s milk products
What does the study involve?
Participants are assessed regarding symptoms of post-dairy digestive discomfort, diet, nutritional status and blood pressure. All participants receive both milk containing A1A2 beta casein and milk containing A2A2 beta casein. They are randomly allocated to receive the milk containing A1A1 beta casein then milk containing A2A2 beta casein (sequence 1) or milk containing A2A2 beta casein then milk containing A1A2 beta casein (sequence 2). Each participant consumes two bottles of 200 ml of milk daily for 2 weeks. Both types of milk are provided by ABC KOGEN. To ensure that the sample is actually consumed by participants, they have to consume the milk at the Center for Nutrition and Health room on weekdays and at weekdays the milk is taken home by the participants then they return the used bottle. There is a two-week break between consuming the two types of milk where the participants are not allowed to consume cow’s milk products in order to remove or clear the effects of the previous milk. Participants fill out two weekdays and one weekend food diary to monitor their diet. Participants are also given a list of foods as a substitute for the source of nutrition from dairy products. Participants fill out forms about the symptoms of post-dairy digestive discomfort and stool frequency and consistency, and provide blood samples before and after the intervention to measure their immune response.
What are the possible benefits and risks of participating?
Participants will get some benefit such as knowing their body's immune response to dairy products. Overall data collection has no risks. However, an error of the screening procedure may occur so that poses a risk to this research. To minimize the risk, all data are collected by trained personnel according to the standard procedures. In addition, all of the participants are insured and receive treatment if there are any health complaints during this study.
Where is the study run from?
Universitas Indonesia
When is the study starting and how long is it expected to run for?
August 2017 to April 2018
Who is funding the study?
ABC Kogen
Who is the main contact?
Dr Ahmad Syafiq
Contact information
Scientific
Room 204, F Building, 2nd floor
Faculty of Public Health
Universitas Indonesia
Depok, West Java
16424
Indonesia
Study information
| Study design | Interventional double-blind randomized two-way cross-over single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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) |
| Study objectives | Milk containing A2A2 beta casein decreases the symptoms of post-dairy digestive discomfort and improves immune response more than milk containing A1A2 beta casein. |
| Ethics approval(s) | Committee of Ethics Research and Public Health Service, Faculty of Public Health, Universitas Indonesia, 13/10/2017, ref: 529/UN2.F10/PPM.00.02/2017 |
| Health condition(s) or problem(s) studied | Post-diary digestive discomfort |
| Intervention | 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 the milk containing A1A2 then milk containing A2A2 (sequence 1) or milk containing A2A2 then milk containing A1A2 beta casein (sequence 2). Each participant consumed 200 ml milk twice a day for 2 weeks of intervention. Both types of milk were provided by ABC KOGEN. Before entering second intervention, there are a washout period (intervention-free). In this period, the participants will not get any intervention for 2 weeks to remove or clear the effects of previous intervention. The participants were not allowed to consume dairy products on the washout period during this study. Participants will be given a list of foods as a substitute for the sources of nutrition from dairy products. On intervention period, participants were asked to fill out the form of symptoms of post-dairy digestive discomfort and Bristol Stool Scale as well as taking blood samples. Blood samples were taken within a range of 12 hours before or after the intervention. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/08/2017 |
| Completion date | 19/04/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 participants: 30 participants for sequence 1 and 30 participants for sequence 2 |
| Key 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 |
| Key exclusion criteria | 1. Woman in pregnancy and breastfeeding 2. Consume anti inflammatory or immunosuppressive drugs within 4 weeks before screening 3. Have an allergy |
| Date of first enrolment | 20/10/2017 |
| Date of final enrolment | 09/12/2017 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Faculty of Public Health
Room 204, F Building, 2nd floor
Depok, West Java
16424
Indonesia
Sponsor information
University/education
Centers for Nutrition and Health
Faculty of Public Health
Room 204, F Building, 2nd floor
Depok, West Java
16424
Indonesia
"ROR" |
https://ror.org/03xqzzq44 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | American Journal of Clinical Trial; British Journal of Nutrition; Malaysian Journal of Nutrition |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
