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Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets.
The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults.
Subjects:
40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 .
Protocol:
This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Breakfast with 400 kcal of oat cereal with honey | Sham Comparator |
| |
| Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| powder shake with very low glycemic index | Dietary Supplement | 2 weeks of cereal and standard process glucose assist shake as part of breakfast. The diet for the remainder of the day will remain unchanged. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose response between two breakfasts | The difference between the two breakfasts on the positive integer of the area under the curve for glucose during the 2 hours following breakfast ingestion. | the entire 2 hours of the glycemic test |
| Insulin responses between the two breakfasts | The difference between the two breakfasts on the positive integer of the area under the curve for insulin; during the 2 hours following breakfast ingestion. | The entire 2 hours period |
| Glucose réponses during glucose challenge test | Positive integer of the area under the curve for glucose during the 2 hours glycemic test | 2 hours post ingestion of the emperimental meal (cereal or ceral + shake) |
| Insulin responses during the glucemic challenge test | Positive integer of the area under the curve for insulin during the 2-hours glycemic test | 2 hour post ingestion of the intervention meal (cereal or cereal + shake) |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory glucose profile | The difference between the two groups on the area under the curve in Ambulatory glucose measured with a continuous glucose monitor during the 2 weeks of dietary intervention. | total area under the curve during the 2 weeks (14 days) of dietary intervention. |
| Blood glucagon |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University 850 PBC | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Two arms: one group will undergo 2 weeks of a meal replacement shake for breakfast with oat cereal and the other group will consume only oat cereal (isocaloric 400 kilocarolies)
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| Ceral Breakfast | Dietary Supplement | consume of 400kcal of oat-based cereal with honey for breakfast |
|
Blood glucagon difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
| 0, 30, 60, 90, and 120 minutes of the glycemic test. |
| Glucagon like peptide 1 | Blood Glucagon like peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) | 0, 30, 60, 90, and 120 minutes of the glycemic test. |
| Leptin | Blood Leptin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) | 0, 30, 60, 90, and 120 minutes of the glycemic test. |
| Adiponectin | Blood Adiponectin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) | 0, 30, 60, 90, and 120 minutes of the glycemic test. |
| Ghrelin | Blood Ghrelin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) | 0, 30, 60, 90, and 120 minutes of the glycemic test. |
| C-Peptide | Blood c-peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) | 0, 30, 60, 90, and 120 minutes of the glycemic test. |