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| Name | Class |
|---|---|
| Simply Good Foods USA, Ltd. | UNKNOWN |
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The goal of this clinical trial is to determine the effect of a low carbohydrate higher protein diet, modelled after the Atkins program on weight loss, glycemic control, risk markers of cardiovascular disease and body composition in patients taking semaglutide.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Carbohydrate | Experimental | Subjects randomized to the low-carbohydrate arm will be instructed on a reduced calorie diet (<1400 kcal/day) consisting of an average macronutrient distribution of 20% carbohydrate, 30% protein and 50% fat with a maximum intake of 40g/day of available (net) carbohydrates (approximately 65-75g total carbohydrates). To complement the provided low carbohydrate shakes and snacks, dietary counselling will focus on choosing sources of protein and non-starchy vegetables |
|
| Low Fat | Active Comparator | Subjects randomized to the low-fat arm will be instructed on a reduced calorie diet (<1400 kcal/day) consisting of an average macronutrient distribution of 50% carbohydrate, 20% protein and 30% fat, with a maximum intake of 50g/day of fat. To complement the provided low fat shakes and snacks, dietary counselling will focus on choosing lean sources of protein and carbohydrates, while limiting high fat foods such as oils, nuts, full fat dairy, and fatty meats. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Carbohydrate | Behavioral | Low carbohydrate diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Percentage change from baseline of body weight | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Change from baseline of BMI | 12 weeks |
| Fat Mass | Change from baseline of Fat Mass | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Campbell | INQUIS Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INQUIS Clinical Research | Toronto | Ontario | M5C2N8 | Canada |
Permission has not been sought to do so. Not shared to protect personal health information and participant identity.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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Randomized, open-label parallel design
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| Low Fat |
| Behavioral |
Low fat diet |
|
| Fasting plasma glucose | Change from baseline of fasting plasma glucose | 12 weeks |
| Fat-free mass | Change from baseline of Fat-Free Mass | 12 weeks |
| Skeletal Muscle Mass | Change from baseline of Skeletal Muscle Mass | 12 weeks |
| Fasting serum insulin | Change from baseline of fasting serum insulin | 12 weeks |
| Insulin sensitivity index | Change from baseline of HOMA-IR | 12 weeks |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |