An interventional study of Reduced Meat High Potato Diet and Reduced Meat High Pulses Diet in Insulin Resistance and Obesity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
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Exclusion Criteria:
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.
Other: Reduced Meat High Potato 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. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Other: Reduced Meat High Pulses 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.
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.
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.
Time frame: Baseline and 8 weeks
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.
Time frame: Baseline and 8 weeks
Cholesterol Response to the Diet
change in blood cholesterol (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks
| Milestone | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| Started | 18 | 18 |
| Completed | 14 | 17 |
| Not completed | 4 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Covid-19 | 3 | 0 |
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.
| mg/dL/min | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| Glycemic Response to the Diet | -103.44 ± 430.04 | -501.91 ± 406.83 |
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.
| uU/ml/min | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| Insulin Response to the Diet | -966.63 ± 1012.49 | -2136.32 ± 955.53 |
change in blood cholesterol (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.
| mg/dL | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| Cholesterol Response to the Diet | -5.01 ± 3.57 | -11.79 ± 3.25 |
change in blood triglyceride (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.
| mg/dL | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| Triglyceride Response to the Diet | -4.67 ± 19.25 | -2.88 ± 17.94 |
change in LDL particle size (nm) in response to the diet. Negative values are considered a better outcome.
| nm | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| LDL Particle Size Response to the Diet | -0.27 ± 0.13 | -0.38 ± 0.12 |
change in hsCRP (mg/L) in response to the diet. Positive values are considered a worse outcome.
| mg/L | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| hsCRP Response to the Diet | 0.51 ± 1.43 | 0.24 ± 1.32 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Potatoes Lean Meat (PLM) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Lean Meat Pulses (LMP) | 0/18 (0%) | 0/18 (0%) | 2/18 (11.1%) |
| Event | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) |
|---|---|---|
| gastrointestinalGastrointestinal disorders | 0/18 | 2/18 |
| Age, Continuous(Years and standard error) | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) | Total |
|---|---|---|---|
| Mean | 44.6 ± 2.6 | 45.4 ± 2.6 | 45 ± 1.8 |
| Sex: Female, Male(Participants) | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) | Total |
|---|---|---|---|
| Female | 14 | 14 | 28 |
| Male | 4 | 4 | 8 |
| Race/Ethnicity, Customized(Participants) | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) | Total |
|---|---|---|---|
| White | 11 | 12 | 23 |
| Non-White | 7 | 6 | 13 |
| Region of Enrollment(participants) | Potatoes Lean Meat (PLM) | Lean Meat Pulses (LMP) | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
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Pennington Biomedical Research Center