NCT02779790

Brief Summary

Obesity is a major risk factor for cardiovascular disease and diabetes. Weight loss is an important therapeutic goal for overweight and obese patients to reduce their risk of developing cardiovascular disease and diabetes. Liquid meal replacements (LMRs) are simple tools that may aid in weight loss and may improve weight-related risk cardiometabolic risk factors. There is a need to synthesize the evidence on LMRs and cardiometabolic risk to inform clinical practice guidelines. The authors propose to conduct a series of systematic review and meta-analysis of randomized controlled trials to evaluate the effect of LMRs on 4 areas of cardiometabolic risk: markers of adipsoity, glycemic control, established lipid targets, and blood pressure.

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 Apr 2016

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

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

May 13, 2016

Last Update Submit

May 18, 2016

Conditions

OverweightObesityType 2 Diabetes

Keywords

Systematic Review and Meta-AnalysisEvidence-Based MedicineEvidence-Based NutritionClinical Practice GuidelinesLiquid Meal ReplacementsBody WeightSystolic Blood PressureDiastolic Blood PressureFasting Blood GlucoseFasting Blood InsulinHbA1cTotal CholesterolTriglyceridesLDL-CHDL-CControlled Feeding Trials

Outcome Measures

Primary Outcomes (14)

  • Markers of adiposity - body weight

    Body weight

    Up to 20 years

  • Markers of adiposity - Body Mass Index

    Body Mass Index (BMI)

    Up to 20 years

  • Markers of adiposity - body fat

    Body fat

    Up to 20 years

  • Markers of adiposity - waist circumference

    Waist circumference

    Up to 20 years

  • Glycemic control - HbA1c

    HbA1c

    Up to 20 years

  • Glycemic control - fasting glucose

    fasting glucose

    Up to 20 years

  • Glycemic control - fasting insulin

    fasting insulin

    Up to 20 years

  • Established therapeutic lipid targets - LDL-cholesterol

    LDL-cholesterol (LDL-C)

    Up to 20 years

  • Established therapeutic lipid targets - apolipoprotein B

    Apolipoprotein B (apo B)

    Up to 20 years

  • Established therapeutic lipid targets - non-HDL-cholesterol

    non-HDL-cholesterol (non-HDL-C)

    Up to 20 years

  • Established therapeutic lipid targets - HDL-cholesterol

    HDL-cholesterol (HDL-C)

    Up to 20 years

  • Established therapeutic lipid targets - triglycerides

    Triglycerides

    Up to 20 years

  • Blood pressure - systolic blood pressure

    Systolic blood pressure

    Up to 20 years

  • Blood pressure - diastolic blood pressure

    Diastolic blood pressure

    Up to 20 years

Interventions

Liquid Meal ReplacementsOTHER

An intervention that contains a mixture of protein, carbohydrate, and fat, along with added vitamins and minerals in liquid ready-to-drink or powder formulas that require mixing.

Also known as: Meal Replacement Shakes

Eligibility Criteria

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

Overweight/Obese, both children and adults.

You may qualify if:

  • Trials in humans
  • Liquid meal replacement intervention
  • Presence of a comparator diet (control diet)
  • Diet duration \>=2 weeks
  • Viable outcome data

You may not qualify if:

  • Non-human trials
  • Observational studies
  • Lack of suitable comparator diet
  • No viable outcome data

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 (1)

  • Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.

    PMID: 12704397BACKGROUND

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2Body Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • John 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

May 13, 2016

First Posted

May 20, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

CA(1)