Obesity
Conditions
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.
Interventions
Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.
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.
Sponsors
McMaster University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 0 months | Average number of participants recruited per month |
| Retention rate in arm 1 | 5 months | Percent of enrolled participants who complete the study |
| Retention rate in arm 2 | 5 months | Percent of enrolled participants who complete the study |
| Adherence to the dietary intervention in arm 1 | 2 to 5 months | 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 | 2 to 5 months | Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls |
Countries
Canada
Contacts
Primary ContactNatalia McInnes
Outcome results
None listed