Back to resultsEvaluation of Food Additive Contributions to Obesity - Feasibility Study 2
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring dietary modification
Eligibility Criteria
Inclusion Criteria:
- BMI>/=30 kg/m2
- routine consumption/use of (i) >/=250 ml of artificially-sweetened beverages per day and/or (ii) >/=1 gum per day
- willingness and ability to follow the proposed dietary intervention
- informed consent
Exclusion Criteria:
- previous or planned bariatric surgery in the next 1 year
- current or planned participation in any structured weight-loss programs in the next 6 months
- current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
- bipolar disorder or attention deficit hyperactivity disorder
- current use of anti-depressant or anti-psychotic medications
- eating disorder or any other active disorder that may lead to significant weight changes
- working night shifts
- pregnancy or planned pregnancy in the next 1 year
- uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary intervention
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
Retention rate
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls
Adherence to the dietary intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03758378
Brief Title
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
Official Title
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient number of participants met the study eligibility criteria.
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
dietary modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
Limiting dietary exposure to high intensity sweeteners and sugar alcohols; limiting eating out to a maximum of 2 days per week.
Primary Outcome Measure Information:
Title
Recruitment rate
Time Frame
Baseline
Title
Retention rate
Time Frame
5 months
Title
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls
Description
Adherence to the dietary intervention
Time Frame
2 to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI>/=30 kg/m2
routine consumption/use of (i) >/=250 ml of artificially-sweetened beverages per day and/or (ii) >/=1 gum per day
willingness and ability to follow the proposed dietary intervention
informed consent
Exclusion Criteria:
previous or planned bariatric surgery in the next 1 year
current or planned participation in any structured weight-loss programs in the next 6 months
current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
bipolar disorder or attention deficit hyperactivity disorder
current use of anti-depressant or anti-psychotic medications
eating disorder or any other active disorder that may lead to significant weight changes
working night shifts
pregnancy or planned pregnancy in the next 1 year
uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
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