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This study will evaluate whether enteric-coated nutrients increase some glucose and regulating hormone levels, glucose tolerance and satiety in overweight and obese individuals with type 2 diabetes.
Direct delivery of nutrient to the upper intestine by enteral feeding tube can increase circulating levels of some glucose and appetite regulating hormones when compared to usual oral ingestion. Such an enhancement could be of value in the management of type 2 diabetes and obesity. In this study enteric-coated nutrients will be ingested to allow for direct delivery of nutrient to the upper intestine. Levels of select hormones and glucose, and measures of satiety and adverse effects will be compared following the ingestion of uncoated and enteric coated nutrient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coated Sucrose plus Whole Milk | Active Comparator | 200kcal sucrose plus whole milk powder in enteric coating as single dose |
|
| Non Coated Sucrose plus Whole Milk | Placebo Comparator | 200kcal sucrose plus whole milk powder with separate enteric coating materials as single dose |
|
| Enteric Coated Sucrose | Active Comparator | 200kcal sucrose in enteric coating as single dose |
|
| Non-Enteric Coated Sucrose | Placebo Comparator | 200kcal sucrose with separate enteric coating materials as single dose |
|
| Enteric Coated Whey Protein | Active Comparator | 200kcal whey protein in enteric coating as single dose |
|
| Non-Enteric Coated Whey Protein |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose plus Whole Milk Powder in Enteric Coating | Dietary Supplement | Single dose enteric coated sucrose plus whole milk powder will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in AUC of GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of blood GLP-1 on meal tolerance tests. | From ingestion to 3 hours post ingestion. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Peak PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Highest level of blood PYY on 3 hour meal tolerance test | From ingestion to 3 hours post ingestion. |
| Difference in Peak C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. |
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Inclusion Criteria:
Exclusion Criteria:
Conditions
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Beale, MD | University of Southern California, Keck School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Diabetes & Obesity Research Institute (DORI) | Los Angeles | California | 90033 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 12, 2022 | |
| Reset | Sep 25, 2023 |
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| Placebo Comparator |
200kcal whey protein with separate enteric coating materials as single dose |
|
| Enteric Coated Pea Protein | Active Comparator | 200kcal pea protein in enteric coating as single dose |
|
| Non-Enteric Coated Pea Protein | Placebo Comparator | 200kcal pea protein with separate enteric coating materials as single dose |
|
|
| Non coated Sucrose plus Whole Milk | Dietary Supplement | Single dose sucrose plus whole milk powder with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
| Sucrose in Enteric Coating | Dietary Supplement | Single dose enteric coated sucrose will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
| Sucrose with Separate Enteric Coating Materials | Dietary Supplement | Single dose sucrose with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
| Whey Protein in Enteric Coating | Dietary Supplement | Single dose enteric coated whey protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
| Whey Protein with Separate Enteric Coating Materials | Dietary Supplement | Single dose whey protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
| Pea Protein in Enteric Coating | Dietary Supplement | Single dose enteric coated pea protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
| Pea Protein with Separate Enteric Coating Materials | Dietary Supplement | Single dose pea protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes. |
|
Highest level of blood C-peptide on 3 hour meal tolerance test |
| From ingestion to 3 hours post ingestion. |
| Difference in Peak insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Highest level of blood insulin on 3 hour meal tolerance test | From ingestion to 3 hours post ingestion. |
| Difference in Peak glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Highest level of blood glucose on 3 hour meal tolerance test | From ingestion to 3 hours post ingestion. |
| Difference in Peak satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Highest level of satiety on 3 hour meal tolerance test measured on a 15mm visual analog scale | From ingestion to 3 hours post ingestion. |
| Difference in Peak Adverse Events on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Highest level of adverse symptoms on 3 hour meal tolerance test measured on a 15mm visual analog scale | From ingestion to 3 hours post ingestion. |
| Difference in AUC of PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of blood PYY on meal tolerance tests. | From ingestion to 3 hours post ingestion. |
| Difference in AUC of C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of blood C-peptide on meal tolerance tests. | From ingestion to 3 hours post ingestion. |
| Difference in AUC of insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of blood insulin on meal tolerance tests. | From ingestion to 3 hours post ingestion. |
| Difference in AUC of glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of blood glucose on meal tolerance tests. | From ingestion to 3 hours post ingestion. |
| Difference in AUC of satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of satiety on meal tolerance tests of adverse symptoms on 3 hour meal tolerance test measured on a 15mm visual analog scale | From ingestion to 3 hours post ingestion. |
| Difference in AUC of adverse symptoms on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Integrated Area under the curve (AUC) levels of adverse symptoms on meal tolerance tests of adverse symptoms on 3 hour meal tolerance test measured on a 15mm visual analog scale | From ingestion to 3 hours post ingestion. |
| Difference in Peak GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. | Highest level of blood GLP-1 on 3 hour meal tolerance test | From ingestion to 3 hours post ingestion. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 12, 2022 | Sep 25, 2023 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| D000067816 | Whey Proteins |
| D000078724 | Pea Proteins |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D014674 | Plant Proteins, Dietary |
| D010940 | Plant Proteins |
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