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| Name | Class |
|---|---|
| Martin, Corby, K., M.D. | INDIV |
| Owen T. Carmichael | UNKNOWN |
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The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.
Dose: Participants are to consume 1 unit per day of the study product.
Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Sweetened Solid Treatment | Active Comparator | A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. |
|
| Sugar Sweetened Beverage Treatment | Active Comparator | 20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar Sweetened Solid Treatment | Other | Consume Sugar Sweetened Solid Treatment (product) daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change from baseline in body weight at 1 month | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Sweetened Solid Treatment | A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily. |
| FG001 | Sugar Sweetened Beverage Treatment | 20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Sweetened Solid Treatment | A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily. |
| BG001 | Sugar Sweetened Beverage Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Body Weight | Change from baseline in body weight at 1 month | Posted | Mean | Standard Error | kg | 1 month |
|
4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Sweetened Solid Treatment | A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Apolzan | Pennington Biomedical Research Center | 225-763-2827 | john.apolzan@pbrc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2018 | Aug 26, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 8, 2018 | Aug 26, 2019 | Prot_001.pdf |
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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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A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
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| Sugar Sweetened Beverage Treatment | Other | Consume Sugar Sweetened Beverage Treatment (product) daily. |
|
|
20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sugar Sweetened Beverage Treatment | 20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |