pHNCT04717778
Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children
A study testing Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk in people with pH, run by Universidad Tecnologica de Mexico at 1 site in Mexico.
Trial summary
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk) Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- pH
- What is being tested?
- Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteMexico
- Study dates
- 13 Jan 2020to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys and girls from 3 to 6 years
Who cannot join
- Boys and girls with allergies
- Children with lactose intolerance
- Elimination criteria:
- Boys and girls who do not want to participate at the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk)
Read the detailed description
- The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
- The group was given a brushing technique using a model and 2 videos were shown to reinforce the brushing technique and explanation of what was going to be done in the study.
- Supervised tooth brushing was performed in a group of 5 people.
- They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
- Each child was given 7 plastic cups each day and asked to pour their saliva into the cup when instructed.
- The samples were taken with pH indicator strips and the result was recorded in personalized tables.
- Conditions
- pH
- Being tested
- Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of salivary pH after consuming milk of origin vegetable vs cow's milkDietary supplement
Also called cow´s milk, coconut milk, almond milk, soy milk and rice milk
They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
| Study group | Role | What they receive |
|---|---|---|
| pH milk | Experimental | Group of children who were given the different types of milk and only the pH was measured Receives: Dietary Supplement: Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic results
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
Measured: 1 hour the sociodemographic data of all the children were taken.
pH results
30 minutes after tooth brushing, each child was asked for the first saliva sample (basal pH measurement).
After taking the basal pH, each child was given a glass with 50 ml of the milk to be measured.
Saliva samples were measured with pH indicator strips and the result was recorded on custom charts.
The pH was taken at 5, 10, 20, 30, 40 and 50 minutes.
The normality distribution test (Shapiro-Wilk) was applied to the quantitative variables, with p = 0.0001, so that the data present a non-parametric or free distribution.
To assess whether there were differences between the pH of the groups, the Kuskal-Wallis test was applied. For basal pH, p = 0.0001, therefore the null hypothesis is rejected and we conclude that the basal pH level is different in the five milks. Average basal pH:
Rice milk 7 Cow milk 6.9 Almond milk 6.6 Soy milk 6.4 Coconut milk 6
Measured: The average time of pH evaluation for each milk per child was an hour and a half.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Jan 2020
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for pHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study was carried out in 21 first grade primary school children, they were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Tecnologica de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annia Marisol Avalos Mejía, Universidad Tecnologica de Mexico
- Investigators
- Annia Avalos, Master, Principal investigator, Universidad Tecnológica Centroamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717778
- Sponsor's protocol ID
- 2019-100
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are working on the article to publish it and for the study to be available.
Publications
Vanga SK, Raghavan V. How well do plant based alternatives fare nutritionally compared to cow's milk? J Food Sci Technol. 2018 Jan;55(1):10-20. doi: 10.1007/s13197-017-2915-y. Epub 2017 Nov 2.
PubMed 29358791Hettinga K, van Valenberg H, de Vries S, Boeren S, van Hooijdonk T, van Arendonk J, Vervoort J. The host defense proteome of human and bovine milk. PLoS One. 2011 Apr 27;6(4):e19433. doi: 10.1371/journal.pone.0019433.
PubMed 21556375Cuppari C, Manti S, Salpietro A, Dugo G, Gitto E, Arrigo T, Sturiale M, Salpietro C. ALMOND MILK: A POTENTIAL THERAPEUTIC WEAPON AGAINST COW'S MILK PROTEIN ALLERGY. J Biol Regul Homeost Agents. 2015 Apr-Jun;29(2 Suppl 1):8-12.
PubMed 26634581
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children
- ClinicalTrials.gov ID
- NCT04717778
- Acronym / sponsor ID
- 2019-100
- Conditions
- pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidad Tecnologica de MexicoUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk)
Detailed description
- The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
- The group was given a brushing technique using a model and 2 videos were shown to reinforce the brushing technique and explanation of what was going to be done in the study.
- Supervised tooth brushing was performed in a group of 5 people.
- They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
- Each child was given 7 plastic cups each day and asked to pour their saliva into the cup when instructed.
- The samples were taken with pH indicator strips and the result was recorded in personalized tables.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was carried out in 21 first grade primary school children, they were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
| Arm | Type | Receives |
|---|---|---|
| pH milk | Experimental | Dietary Supplement: Comparison of salivary pH after consuming milk of origin vegetable vs cow's milkGroup of children who were given the different types of milk and only the pH was measured |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Boys and girls from 3 to 6 years
Key exclusion criteria (4 listed)
- Boys and girls with allergies
- Children with lactose intolerance
- Boys and girls who do not want to participate at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of salivary pH after consuming milk of origin vegetable vs cow's milkAlso: cow´s milk, coconut milk, almond milk, soy milk and rice milkThey were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk). | Dietary supplement | pH milk |
Primary outcome
Sociodemographic results
Time frame: 1 hour the sociodemographic data of all the children were taken.
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
pH results
Time frame: The average time of pH evaluation for each milk per child was an hour and a half.
30 minutes after tooth brushing, each child was asked for the first saliva sample (basal pH measurement). After taking the basal pH, each child was given a glass with 50 ml of the milk to be measured. Saliva samples were measured with pH indicator strips and the result was recorded on custom charts. The pH was taken at 5, 10, 20, 30, 40 and 50 minutes. The normality distribution test (Shapiro-Wilk) was applied to the quantitative variables, with p = 0.0001, so that the data present a non-parametric or free distribution. To assess whether there were differences between the pH of the groups, the Kuskal-Wallis test was applied. For basal pH, p = 0.0001, therefore the null hypothesis is rejected and we conclude that the basal pH level is different in the five milks. Average basal pH: Rice milk 7 Cow milk 6.9 Almond milk 6.6 Soy milk 6.4 Coconut milk 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 29358791Vanga SK, Raghavan V. How well do plant based alternatives fare nutritionally compared to cow's milk? J Food Sci Technol. 2018 Jan;55(1):10-20. doi: 10.1007/s13197-017-2915-y. Epub 2017 Nov 2.
- Background: PubMed 21556375Hettinga K, van Valenberg H, de Vries S, Boeren S, van Hooijdonk T, van Arendonk J, Vervoort J. The host defense proteome of human and bovine milk. PLoS One. 2011 Apr 27;6(4):e19433. doi: 10.1371/journal.pone.0019433.
- Background: PubMed 26634581Cuppari C, Manti S, Salpietro A, Dugo G, Gitto E, Arrigo T, Sturiale M, Salpietro C. ALMOND MILK: A POTENTIAL THERAPEUTIC WEAPON AGAINST COW'S MILK PROTEIN ALLERGY. J Biol Regul Homeost Agents. 2015 Apr-Jun;29(2 Suppl 1):8-12.
- Individual participant dataSharing planned: No. We are working on the article to publish it and for the study to be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annia Avalos, Master principal investigator
Universidad Tecnológica Centroamericana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk in people with pH, run by Universidad Tecnologica de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic results (time frame: 1 hour the sociodemographic data of all the children were taken.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717778, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.