NCT02879500

Brief Summary

Sugars especially in form or sugar-sweetened beverages (SSBs) have been singled out as one of the prime culprits in the dual epidemics of obesity and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means for displacing excess calories from free sugars in the diet. There is, however, a concern that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes. This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that sugars in the diet not be replaced with ASBs but rather with "healthy options" such as water. Whether ASBs as a replacement strategy for SSBs have the intended benefits and whether these benefits are similar to those of the preferred replacement strategy water remains unclear. To address this important question and update of the European Association of the Study (EASD) clinical practice guidelines for nutrition therapy, the investigators propose to conduct a series of systematic reviews and network meta-analyses of the totality of the evidence from randomized controlled trials to evaluate the effects of water and ASBs on incident overweight and obesity and cardiometabolic risk factors. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence/base guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovations, and guiding future research design.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

4.3 years

First QC Date

August 22, 2016

Last Update Submit

February 21, 2020

Conditions

OverweightObesity

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesRandomized controlled trialsProspective cohort studiesBody weightBody mass indexAdiposityOverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Adiposity - Body weight

    body weight

    Up to 20 years

Secondary Outcomes (20)

  • Adiposity - BMI

    Up to 20 years

  • Adiposity - Body fat

    Up to 20 years

  • Adiposity - waist circumference (WC)

    Up to 20 years

  • Glycemic control - HbA1c

    Up to 20 years

  • Glycemic control - fasting plasma glucose (FPG)

    Up to 20 years

  • +15 more secondary outcomes

Interventions

Diet beveragesOTHER

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All individuals, both children and adults, regardless of health status

You may qualify if:

  • Trials in humans
  • Diet beverage intervention
  • Water comparator
  • Diet duration \>= 7 days
  • Viable outcome data

You may not qualify if:

  • Non-human trials
  • Observational studies
  • Lack of suitable comparator
  • Diet duration \< 2 weeks
  • No viable outcome data
  • Cohort studies
  • Prospective cohort studies or case-cohort studies
  • Duration \>= 1year
  • Assessment of the exposure of diet beverages or water
  • Ascertainment of viable data by level of exposure
  • Ecological, cross-sectional, and retrospective observational studies, clinical trials and non-human studies
  • Duration \< 1 year
  • No assessment of exposures of diet beverages or water
  • No ascertainment viable clinical outcome data by level of exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

OverweightObesityBody Weight

Interventions

Artificially Sweetened Beverages

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • John L Sievenpiper, MD, PhD, FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)