Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Dairy Council | OTHER |
Not provided
Not provided
Not provided
Not provided
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
Protein consumption in the morning has been shown to reduce appetite and caloric intake (19). In addition, premeal whey consumption reduces post prandial blood glucose, reduces gastric emptying rate, and increases peak blood insulin (10). Thus, it is proposed that ingestion of whey protein within 1hr of waking (and prior to breakfast) and 30 minutes prior to dinner will be more effective in suppressing appetite, carbohydrate intake, and glucose AUC. Ingestion upon waking will mitigate the cortisol-induced drive for carbohydrate intake. Ingestion prior to dinner, the most frequently consumed and largest meal in America (20), will reduce food intake, post meal blood glucose, and insulin area under the curve (21).
Specific Aims
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey Protein Supplementation | Experimental | Crossover study |
|
| Placebo Supplementation | Placebo Comparator | Crossover study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein Isolate Crossover | Dietary Supplement | This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole body protein turnover | Whole body protein turnover reflects the continual synthesis and breakdown of body proteins. It can be measured at a whole-body or tissue level using stable isotope methods. | 7 days |
| Oral Glucose Tolerance Test | Oral Glucose Tolerance Test (OGTT) is used to screen for or diagnose diabetes. Normal blood values for a 75 gram OGTT are: Fasting -- 60 to 99 mg/dL (3.3 to 5.5 mmol/L), 1 hour -- Less than 200 mg/dL (11.1 mmol/L), 2 hours -- Less than 140 mg/dL (7.8 mmol/L) is normal. | 7 days |
| Blood glucose | Continuous glucose monitoring means using a device to automatically estimate your blood glucose level, also called blood sugar, throughout the day and night for 7 days. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Appetite Scale | A composite appetite scale is a measure used to assess appetite control and influence energy intake. It can be calculated based on factors such as hunger, desire to eat, and fullness rating. Appetite Scale: How Hungry do you feel? Not Hungry at all <---> Have never been more Hungry How Satisfied do you feel? Completely empty <----> Can't eat another bite How Full do you feel? Not full at all <----> Totally full The more a person is satisfied and feels full and less hungry, the better the outcome is for whey vs placebo supplementation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arny Ferrando, PhD | Contact | 5015265711 | aferrando@uams.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
The study will enroll 20 prediabetic (A1C 5.7%-6.4%) and 20 diabetic (A1C 6.5%-7.5%) subjects, 50-70 yrs of age, in randomized, crossover fashion. Each subject will participate in two 7d studies, with and without Whey Protein ingestion. Study order will be randomized. Subjects will consume their habitual diets (recorded by dietary log), with the dietary intervention being the additional consumption of two 30g doses of whey on the treatment assignment. Thirty grams of whey or placebo will be ingested within 1hr of waking and prior to breakfast, and a second 30g dose of WPI will be consumed 30min prior to the dinner meal. Main outcomes will be Matsuda index, 24hr glucose AUC, dietary intake (total kcal and macronutrients), and whole-body protein balance. The Matsuda index utilizes an oral glucose tolerance test to derive insulin sensitivity as assessed by euglycemic insulin clamp. Secondary outcomes will be satiety, satiation, and appetite score.
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | 1 week of Non-whey protein Placebo supplement |
|
| 7 days |
| Dietary Intake Log | A dietary intake log, also known as a food diary, is a self-reported account of all foods and beverages consumed within a specific timeframe. | 7 days |
| D004700 | Endocrine System Diseases |