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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04717778
Other study ID # 2019-100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2020
Est. completion date January 17, 2020

Study information

Verified date January 2021
Source Universidad Tecnologica de Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 17, 2020
Est. primary completion date January 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Mexico UNITEC Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Universidad Tecnologica de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sociodemographic results The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. 1 hour the sociodemographic data of all the children were taken.
Primary 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
The average time of pH evaluation for each milk per child was an hour and a half.
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