Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alliance for Potato Research and Education | OTHER |
Not provided
Not provided
Not provided
Not provided
The potato is a nutritious food that comprises approximately 30% of total vegetable intake in the United States (US). Consumption of pulses in the US is low but its contribution to health is frequently promoted. However, in the US diet, potatoes contribute as much dietary fiber, far more potassium, and a host of similar nutrients as pulses. When prepared to enhance its slowly digested starch content, potatoes produce a moderate glycemic response. In encouraging a shift towards plant-based foods and sustainable diets, the potato can partially replace meat in meat dishes to enhance the overall quality of the diet and reduce meat intake to recommended levels.
Approximately 11% of individuals with untreated prediabetes progress to diabetes every year. Reversion to normal blood glucose concentrations reduces the incidence of diabetes by 56%. Healthy eating patterns such as the DASH and the Mediterranean Diet have shown that high intakes of fruits, vegetables, whole grains, legumes or pulses, and potatoes are associated with cardiometabolic health. In contrast, dietary patterns rich in meat and sugar-rich foods are associated with increased risk of mortality, type 2 diabetes, and coronary heart disease. These findings suggest that it may be prudent to replace certain foods with fruits and vegetables rather than simply embrace plant-based diets. Small changes that bestow health benefits are likely to be sustainable in the long-term. The objective of the present application is to develop a diet intervention to reverse insulin resistance in an overweight or obese population. The central hypothesis is that in the context of an overall healthy eating pattern, potatoes and pulses will not differ in the glycemic and insulinemic responses, lipid profile, and hsCRP concentration they elicit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potatoes Lean Meat (PLM) | Experimental | The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet. |
|
| Lean Meat Pulses (LMP) | Experimental | The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Meat High Potato Diet | Other | The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Response to the Diet | Change in area under the curve for blood glucose (mg/dL/min) concentration in response to the diet. Negative values are considered a better outcome. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Response to the Diet | change in area under the curve for blood insulin (uU/mL/min) concentration in response to the diet. Negative values are considered a better outcome. | Baseline and 8 weeks |
| Cholesterol Response to the Diet |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Kirwan, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36367708 | Derived | Rebello CJ, Beyl RA, Greenway FL, Atteberry KC, Hoddy KK, Kirwan JP. Low-Energy Dense Potato- and Bean-Based Diets Reduce Body Weight and Insulin Resistance: A Randomized, Feeding, Equivalence Trial. J Med Food. 2022 Dec;25(12):1155-1163. doi: 10.1089/jmf.2022.0072. Epub 2022 Nov 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Potatoes Lean Meat (PLM) | The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet. Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. |
| FG001 | Lean Meat Pulses (LMP) | The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day. Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Potatoes Lean Meat (PLM) | The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet. Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Response to the Diet | Change in area under the curve for blood glucose (mg/dL/min) concentration in response to the diet. Negative values are considered a better outcome. | Posted | Least Squares Mean | Standard Error | mg/dL/min | Baseline and 8 weeks |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Potatoes Lean Meat (PLM) | The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day. Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Two participants in the Bean diet group reported mild to moderate gastrointestinal effects (flatulence, cramps, and diarrhea). These effects resolved and participants completed the study. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Candida Rebello | Pennington Biomedical Research Center | 2257633159 | Candida.Rebello@pbrc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2019 | Oct 30, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Randomized parallel design
Not provided
Not provided
Investigator and care providers will be blinded to randomization and treatment allocation.
| Reduced Meat High Pulses Diet | Other | The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. |
|
change in blood cholesterol (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.
| Baseline and 8 weeks |
| Triglyceride Response to the Diet | change in blood triglyceride (mg/dL) concentration in response to the diet. Negative values are considered a better outcome. | Baseline and 8 weeks |
| LDL Particle Size Response to the Diet | change in LDL particle size (nm) in response to the diet. Negative values are considered a better outcome. | Baseline and 8 weeks |
| hsCRP Response to the Diet | change in hsCRP (mg/L) in response to the diet. Positive values are considered a worse outcome. | Baseline and 8 weeks |
| BG001 | Lean Meat Pulses (LMP) | The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day. Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. |
| BG002 | Total | Total of all reporting groups |
| Years and standard error |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|
| Secondary | Insulin Response to the Diet | change in area under the curve for blood insulin (uU/mL/min) concentration in response to the diet. Negative values are considered a better outcome. | Posted | Least Squares Mean | Standard Error | uU/ml/min | Baseline and 8 weeks |
|
|
|
| Secondary | Cholesterol Response to the Diet | change in blood cholesterol (mg/dL) concentration in response to the diet. Negative values are considered a better outcome. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and 8 weeks |
|
|
|
| Secondary | Triglyceride Response to the Diet | change in blood triglyceride (mg/dL) concentration in response to the diet. Negative values are considered a better outcome. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and 8 weeks |
|
|
|
| Secondary | LDL Particle Size Response to the Diet | change in LDL particle size (nm) in response to the diet. Negative values are considered a better outcome. | Posted | Least Squares Mean | Standard Error | nm | Baseline and 8 weeks |
|
|
|
| Secondary | hsCRP Response to the Diet | change in hsCRP (mg/L) in response to the diet. Positive values are considered a worse outcome. | Posted | Least Squares Mean | Standard Error | mg/L | Baseline and 8 weeks |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Lean Meat Pulses (LMP) | The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day. Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. | 0 | 18 | 0 | 18 | 2 | 18 |
|
Not provided
Not provided
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |