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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (GERD) in people who are overweight. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. In this study, the investigators also hope to find out if acid in the esophagus is reduced more by a low carbohydrate diet than a low fat diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Carbohydrate Diet | Experimental | Very Low Carbohydrate Diet |
|
| Low Fat Diet | Active Comparator | Low Fat Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet - very low carb or low fat | Other | Diet comparison in Gastroesophageal Reflux Disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in distal esophageal acid exposure after initiating a very low carbohydrate diet compared to the decrease seen after initiating a low fat diet | Baseline, 10 days after baseline, and at 25 days after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in serum levels of pro-inflammatory cytokines after initiating a very low carbohydrate diet compared to a traditional low fat diet as measured with blood samples. | Baseline, 10 days after baseline, and at 25 days after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas J Shaheen, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D050177 | Overweight |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| D004066 | Digestive System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |