Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

Conditions
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Obesity

Intervention / Treatment
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* Other: Dietary intervention 1
* Other: Dietary intervention 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention 1<br> | Other: Dietary intervention 1<br>* Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.<br>|
| Experimental: Dietary intervention 2<br> | Other: Dietary intervention 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Average number of participants recruited per month | 0 months | 
| Retention rate in arm 1 | Percent of enrolled participants who complete the study | 5 months | 
| Retention rate in arm 2 | Percent of enrolled participants who complete the study | 5 months | 
| 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 | 2 to 5 months | 
| 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 | 2 to 5 months |