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| Name | Class |
|---|---|
| Hamilton Academic Health Sciences Organization | OTHER |
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The effects of food additives on body weight in humans are largely unknown. This is a pilot cross-over double blind RCT in obese adults aimed to test the feasibility of measuring food consumption over 24 hours after one-time administration of K sorbate versus placebo after participants reduce the background consumption of related food additives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K sorbate one-time administration followed by washout then placebo one-time administration | Experimental |
| |
| Placebo one-time administration followed by washout then K sorbate one-time administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium sorbate one-time administration followed by washout then placebo one-time administration | Other | K sorbate 450 mg will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then placebo administration with breakfast during testing session 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Through active recruitment period (from the start of the recruitment period to the date the last participant could still be recruited into the study), anticipated to be 6 weeks. | |
| Randomization rate | Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks. | |
| Retention rate at the study end | Percentage of randomized participants who complete 2 testing sessions after randomization | Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks. |
| Adherence to the proposed dietary modifications on 24-hour dietary recalls conducted at or after randomization | From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks. | |
| Adverse events after randomization | From the time of randomization till study completion for each participant, anticipated average of 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia McInnes, MD, MSc | Contact | 19055212100 | 73794 | natalia.mcinnes@mcmaster.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L8S 4K1 | Canada |
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| Placebo one-time administration followed by washout then potassium sorbate one-time administration | Other | Placebo will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then K sorbate 450 mg administration with breakfast during testing session 2 |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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