Condition category
Signs and Symptoms
Date applied
24/05/2018
Date assigned
25/06/2018
Last edited
29/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ahmad Syafiq

ORCID ID

Contact details

Room 204
F Building
2nd floor
Faculty of Public Health
Universitas Indonesia
Depok
West Java
16424
Indonesia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

No.021/SP/AKD/2017

Study information

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)

Acronym

Study hypothesis

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

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

Study design

Interventional double-blind randomized two-way cross-over single-centre study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/08/2017

Overall trial end date

19/04/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

60 participants: 30 participants for sequence 1 and 30 participants for sequence 2

Participant exclusion criteria

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

Recruitment start date

20/10/2017

Recruitment end date

09/12/2017

Locations

Countries of recruitment

Indonesia

Trial participating centre

Universitas Indonesia
Centers for Nutrition and Health Faculty of Public Health Room 204, F Building, 2nd floor
Depok, West Java
16424
Indonesia

Sponsor information

Organisation

Universitas Indonesia

Sponsor details

Centers for Nutrition and Health
Faculty of Public Health
Room 204
F Building
2nd floor
Depok
West Java
16424
Indonesia

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

ABC Kogen

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

American Journal of Clinical Trial; British Journal of Nutrition; Malaysian Journal of Nutrition

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

01/01/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes