Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Meta-analyses of the Effect of Liquid Meal Replacements on Cardiometabolic Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02779790
Recruitment Status : Unknown
Verified May 2016 by John Sievenpiper, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Canadian Diabetes Association
Banting & Best Diabetes Centre
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

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.

Condition or disease Intervention/treatment
Overweight Obesity Type 2 Diabetes Other: Liquid Meal Replacements

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1 participants
Time Perspective: Prospective
Official Title: Effect of Liquid Meal Replacements on Cardiometabolic Risk Factors: A Series of Systematic Reviews and Meta-analyses of Randomized Controlled Trials
Study Start Date : April 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Liquid Meal Replacements
    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.
    Other Name: Meal Replacement Shakes


Primary Outcome Measures :
  1. Markers of adiposity - body weight [ Time Frame: Up to 20 years ]
    Body weight

  2. Markers of adiposity - Body Mass Index [ Time Frame: Up to 20 years ]
    Body Mass Index (BMI)

  3. Markers of adiposity - body fat [ Time Frame: Up to 20 years ]
    Body fat

  4. Markers of adiposity - waist circumference [ Time Frame: Up to 20 years ]
    Waist circumference

  5. Glycemic control - HbA1c [ Time Frame: Up to 20 years ]
    HbA1c

  6. Glycemic control - fasting glucose [ Time Frame: Up to 20 years ]
    fasting glucose

  7. Glycemic control - fasting insulin [ Time Frame: Up to 20 years ]
    fasting insulin

  8. Established therapeutic lipid targets - LDL-cholesterol [ Time Frame: Up to 20 years ]
    LDL-cholesterol (LDL-C)

  9. Established therapeutic lipid targets - apolipoprotein B [ Time Frame: Up to 20 years ]
    Apolipoprotein B (apo B)

  10. Established therapeutic lipid targets - non-HDL-cholesterol [ Time Frame: Up to 20 years ]
    non-HDL-cholesterol (non-HDL-C)

  11. Established therapeutic lipid targets - HDL-cholesterol [ Time Frame: Up to 20 years ]
    HDL-cholesterol (HDL-C)

  12. Established therapeutic lipid targets - triglycerides [ Time Frame: Up to 20 years ]
    Triglycerides

  13. Blood pressure - systolic blood pressure [ Time Frame: Up to 20 years ]
    Systolic blood pressure

  14. Blood pressure - diastolic blood pressure [ Time Frame: Up to 20 years ]
    Diastolic blood pressure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Overweight/Obese, both children and adults.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779790


Locations
Layout table for location information
Canada, Ontario
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, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Canadian Diabetes Association
Banting & Best Diabetes Centre
Investigators
Layout table for investigator information
Principal Investigator: John Sievenpiper, MD, PhD, FRCPC University of Toronto
Publications:
Layout table for additonal information
Responsible Party: John Sievenpiper, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02779790    
Other Study ID Numbers: CIHR-LMRs 2016
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Keywords provided by John Sievenpiper, University of Toronto:
Systematic Review and Meta-Analysis
Evidence-Based Medicine
Evidence-Based Nutrition
Clinical Practice Guidelines
Liquid Meal Replacements
Body Weight
Systolic Blood Pressure
Diastolic Blood Pressure
Fasting Blood Glucose
Fasting Blood Insulin
HbA1c
Total Cholesterol
Triglycerides
LDL-C
HDL-C
Controlled Feeding Trials
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight