Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- McMaster University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dietary intervention
Intervention: Dietary intervention (Other)
Outcomes
Primary Outcomes
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls
Time Frame: 2 to 4 months
Adherence to the dietary intervention
Retention rate
Time Frame: 5 months
Recruitment rate
Time Frame: Baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Natalia McInnes
Associate Professor
McMaster University