Back to resultsEvaluation of Food Additive Contributions to Obesity - Feasibility Study 3
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary intervention 1
Dietary intervention 2
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI >/=30 kg/m2
- willingness and ability to follow the proposed dietary interventions
- 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
- excessive alcohol consumption
- 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
- 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 UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dietary intervention 1
Dietary intervention 2
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
Average number of participants recruited per month
Retention rate in arm 1
Percent of enrolled participants who complete the study
Retention rate in arm 2
Percent of enrolled participants who complete the study
Adherence to the dietary intervention in arm 1
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Adherence to the dietary intervention in arm 2
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04236713
Brief Title
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3
Official Title
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Anticipated)
Study Completion Date
October 15, 2021 (Anticipated)
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 feasibility study in 10 obese adults who will be followed for 5 months. Eligible participants will be non-randomly assigned to 2 groups and will be taught how to limit the exposure to the studied food additives in their diet. 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary intervention 1
Arm Type
Experimental
Arm Title
Dietary intervention 2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dietary intervention 1
Intervention Description
Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.
Intervention Type
Other
Intervention Name(s)
Dietary intervention 2
Intervention Description
Limiting dietary exposure to nitrites, sulfites and related food additives; limiting eating out to a maximum of 2 days per week; limiting drinking wine to a maximum of 2 days per week.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Average number of participants recruited per month
Time Frame
0 months
Title
Retention rate in arm 1
Description
Percent of enrolled participants who complete the study
Time Frame
5 months
Title
Retention rate in arm 2
Description
Percent of enrolled participants who complete the study
Time Frame
5 months
Title
Adherence to the dietary intervention in arm 1
Description
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Time Frame
2 to 5 months
Title
Adherence to the dietary intervention in arm 2
Description
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Time Frame
2 to 5 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
willingness and ability to follow the proposed dietary interventions
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
excessive alcohol consumption
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
pregnancy or planned pregnancy in the next 1 year
uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia McInnes
Phone
905-521-2100
Ext
73794
Email
natalia.mcinnes@mcmaster.ca
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia McInnes, MD, MSc
First Name & Middle Initial & Last Name & Degree
Natalia McInnes
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3
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