NCT04717778

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4 days

First QC Date

January 12, 2021

Last Update Submit

January 15, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (1)

pH milk

EXPERIMENTAL

Group of children who were given the different types of milk and only the pH was measured

Dietary Supplement: Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk

Interventions

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).

Also known as: cow´s milk, coconut milk, almond milk, soy milk and rice milk
pH milk

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Boys and girls from 3 to 6 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNITEC

Mexico City, 11320, Mexico

Location

Related Publications (3)

  • 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.

    PMID: 29358791BACKGROUND
  • 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.

    PMID: 21556375BACKGROUND
  • 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.

    PMID: 26634581BACKGROUND

MeSH Terms

Interventions

Soy Milk

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFoodFood and Beverages

Study Officials

  • Annia Avalos, Master

    Universidad Tecnológica Centroamericana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 22, 2021

Study Start

January 13, 2020

Primary Completion

January 17, 2020

Study Completion

January 17, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

We are working on the article to publish it and for the study to be available.

Locations