Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
1 other identifier
interventional
6
1 country
1
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 will 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2018
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2018
CompletedFirst Submitted
Initial submission to the registry
November 23, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2019
CompletedAugust 20, 2019
August 1, 2019
8 months
November 23, 2018
August 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recruitment rate
0 months
Retention rate
5 months
Adherence to the dietary intervention
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months
2 to 4 months
Study Arms (1)
Dietary intervention
EXPERIMENTALInterventions
Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.
Eligibility Criteria
You may qualify if:
- BMI\>/=30 kg/m2
- willingness and ability to follow the proposed dietary intervention
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8S 4K1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 23, 2018
First Posted
November 29, 2018
Study Start
November 13, 2018
Primary Completion
July 16, 2019
Study Completion
July 16, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share