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 |
|---|---|
| Marlow Foods Ltd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
High-protein (HP) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. They also improve glucose control and so may be helpful for treatment of Type 2 Diabetes (T2D), particularly in the short-term, possibly via an improvement in insulin secretion. Indeed, HP diets may be uniquely effective at promoting insulin secretion in T2D, but further research is needed to understand why HP. Thus, there is an urgent need to determine how HP diets affect T2D pathophysiology of insulin secretion and action using direct measures of β-cell dysfunction and insulin sensitivity. It is also imperative to know how the type of protein (animal vs. non-animal) affects insulin secretion in order to ultimately obtain an environmentally and economically sustainable HP diet that can improve glucose control and T2D pathophysiology in the long-term as well as providing patients with a greater choice for dietary management of T2D.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Animal | Experimental | Arm of the study consuming a high-protein diet from animal sources. |
|
| Non-animal | Experimental | Arm of the study consuming a high-protein diet from non-animal sources. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Other | Controlled dietary intervention; all food is provided to participants after being allocated to animal or non-animal dietary protein, for a duration of 5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Rate of disappearance (Rd) during the hyperinsulinaemic-euglycaemic clamp from participants on each diet, a measure of insulin sensitivity. | Change from Baseline insulin sensitivity after 5-week controlled diet |
| Measure | Description | Time Frame |
|---|---|---|
| β-cell function | β-cell function measured by modelling of glucose, insulin and c-peptide during MMTT | Change from Baseline β-cell function after 5-week controlled diet |
| Glucose control | Glucose control measured by fasting glucose, 2 hour MMTT glucose, 24-hour glucose profile using continuous glucose monitoring probe and HbA1c. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutritional Physiology Research Unit | Exeter | Devon | EX12LU | United Kingdom |
Not provided
| ID | Term |
|---|---|
| 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
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from Baseline glucose control after 5-week controlled diet |
| Branched-chain amino acid (BCAA) metabolism | BCAA metabolism measured by plasma BCAA concentration. | Change from Baseline BCAA after 1, 2, 3, 4 and 5 weeks of controlled diet |
| Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire | Treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ). | Change from Baseline treatment satisfaction after 5-week controlled diet |
| D004700 | Endocrine System Diseases |