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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention 1 | Experimental |
| |
| Dietary intervention 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention 1 | Other | Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia McInnes | Contact | 905-521-2100 | 73794 | natalia.mcinnes@mcmaster.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Recruiting | Hamilton | Ontario | L8S 4K1 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary intervention 2 | Other | 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. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |