- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04717778
Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mexico City, Mexico, 11320
- UNITEC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Boys and girls from 3 to 6 years
Exclusion Criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: pH milk
Group of children who were given the different types of milk and only the pH was measured
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Dietary supplement: Comparison of salivary pH after consuming milk of origin vegetable vs cow's 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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic results
Time Frame: 1 hour the sociodemographic data of all the children were taken.
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The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
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1 hour the sociodemographic data of all the children were taken.
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pH results
Time Frame: The average time of pH evaluation for each milk per child was an hour and a half.
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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 |
The average time of pH evaluation for each milk per child was an hour and a half.
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Collaborators and Investigators
Investigators
- Principal Investigator: Annia Avalos, Master, Universidad Tecnológica Centroamericana
Publications and helpful links
General 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.
- Hettinga 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.
- Cuppari 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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