NCT04297722

Brief Summary

According to statistics from the European Association for the Study of Obesity (EASO), taking into account the definition of overweight and obesity recommended by the International Obesity Task Fort (IOTF), the prevalence of overweight (including obesity) in European children aged 7 to 17 years is 16-22% and the prevalence of obesity is 4-6%. Some review studies3 and meta-analysis4,5 have reported an inverse relationship between dairy products consumption and the prevalence or incidence of overweight and obesity. However, some methodological issues arise from these analyses. For instance, the combination of studies with different exposures (e.g. full fat milk, total milk) in the total dairy product analysis. Moreover, since the publication of the lasts meta-analysis in 2016, new epidemiological studies evaluating the association between dairy product consumption and overweight or obesity risk have been published. Objective The aim of this work is to systematically review and assess the associations between total dairy consumption and its different subtypes with the prevalence and incidence of overweight and obesity in children and adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

March 2, 2020

Last Update Submit

September 27, 2022

Conditions

Keywords

systematic review and meta-analysisdairy productsprospective studiescross-sectional studies

Outcome Measures

Primary Outcomes (2)

  • Overweight or obesity

    Prevalence of overweight and/or obesity

    Baseline

  • Overweight or obesity

    incidence of overweight and/or obesity

    Up to 40 years

Interventions

Dairy consumption including total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese and fresh cheese

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All children (aged 2 years old to 21 years old), regardless of health status

You may qualify if:

  • Cross-sectional and Prospective cohort studies
  • At least 1 year of follow-up (for prospective cohorts)
  • Children and adolescents participants
  • Dairy consumption (total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-f fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese, fresh cheese) as exposure
  • Overweight or obesity as outcomes
  • Odd ratios, risk ratios or hazard ratios and their corresponding 95% confidence interval (CI) as a measure of effect estimators.

You may not qualify if:

  • Ecological, retrospective observational studies, non-human studies, letters, comments, reports, especial articles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Unit

Reus, Tarragona, 43201, Spain

Location

Related Publications (1)

  • Babio N, Becerra-Tomas N, Nishi SK, Lopez-Gonzalez L, Paz-Graniel I, Garcia-Gavilan J, Schroder H, Martin-Calvo N, Salas-Salvado J. Total dairy consumption in relation to overweight and obesity in children and adolescents: A systematic review and meta-analysis. Obes Rev. 2022 Jan;23 Suppl 1:e13400. doi: 10.1111/obr.13400. Epub 2021 Dec 8.

MeSH Terms

Conditions

Pediatric ObesityOverweightObesity

Interventions

Dairy Products

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jordi Salas-Salvadó, Professor

    Rovira i Virgili University, IISPV, CIBERobn

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral researcher at Human Nutrition Unit

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 5, 2020

Study Start

January 13, 2020

Primary Completion

May 29, 2020

Study Completion

December 8, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations