NCT02702440

Brief Summary

Consumption of sugar-sweetened beverages (SSBs) has been linked to rising rates of overweight and obesity. The most prominent mechanism to explain the link between SSBs and obesity is that liquid calories are not perceived by the body; thereby, promoting less satiety, less energy compensation and more weight gain than does the same energy consumed in solid form. This view is supported by pooled analyses of acute preload trials that have primarily measured food intake as the outcome. Though failure of short-term compensation has been observed with liquid calories, results from these acute preload trials should not be extrapolated to infer that liquid energy sources lead to weight gain over the long-term. To date, it is unclear whether liquid calories have differential effects than solid calories on body weight gain over the longer term. To increase clarity in this issue, the investigators propose to conduct a systematic review and meta-analysis from long-term controlled feeding trials to distinguish the contribution of liquid calories from solid calories on body weight over the long-term. The findings generated by this analysis will improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, 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 May 2015

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

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

March 2, 2016

Last Update Submit

May 15, 2016

Conditions

Diabetes MellitusChronic DiseaseCardiovascular DiseasesPrediabetic StateOverweightObesityMetabolic Syndrome

Keywords

Systematic review and meta-analysisSugarsLiquid caloriesSolid caloriesClinical trialsBody weightBody Mass IndexEvidence-base nutrition (EBN)Evidence-base medicine (EBM)Clinical practice guidelines

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Up to 20 years

Interventions

Liquid calories from sugarsOTHER

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:

  • Controlled trials in humans
  • Treatment duration more or equal than 7 days
  • Viable endpoint data (body weight)
  • Suitable control (e,i. Isocaloric exchange of liquid carbohydrates with solid carbohydrates)

You may not qualify if:

  • Non-human studies
  • No viable endpoint data
  • Acute preload studies (\< 7 days)
  • Lack of a suitable control (non-isocaloric)

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

Related Publications (3)

  • Kaiser KA, Shikany JM, Keating KD, Allison DB. Will reducing sugar-sweetened beverage consumption reduce obesity? Evidence supporting conjecture is strong, but evidence when testing effect is weak. Obes Rev. 2013 Aug;14(8):620-33. doi: 10.1111/obr.12048. Epub 2013 Jun 7.

    PMID: 23742715BACKGROUND

  • Almiron-Roig E, Palla L, Guest K, Ricchiuti C, Vint N, Jebb SA, Drewnowski A. Factors that determine energy compensation: a systematic review of preload studies. Nutr Rev. 2013 Jul;71(7):458-73. doi: 10.1111/nure.12048. Epub 2013 Jun 10.

    PMID: 23815144BACKGROUND

  • Allison DB. Liquid calories, energy compensation and weight: what we know and what we still need to learn. Br J Nutr. 2014 Feb;111(3):384-6. doi: 10.1017/S0007114513003309. Epub 2013 Oct 29. No abstract available.

    PMID: 24164833BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusChronic DiseaseCardiovascular DiseasesPrediabetic StateOverweightObesityMetabolic SyndromeBody Weight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersSigns and SymptomsInsulin ResistanceHyperinsulinism

Study Officials

  • John L Sievenpiper, MD, PhD, FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

CA(1)