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Potato Research for Enhancing Metabolic Outcomes (PREMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04203238
Recruitment Status : Suspended (Due to the SARS CoV2 pandemic)
First Posted : December 18, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Alliance for Potato Research and Education
Information provided by (Responsible Party):
John Kirwan, Pennington Biomedical Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Other: Reduced Meat High Potato Diet Other: Reduced Meat High Pulses Diet Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel design
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator and care providers will be blinded to randomization and treatment allocation.
Primary Purpose: Prevention
Official Title: Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Experimental: 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 which is consistent with the DASH diet.
Other: 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.




Primary Outcome Measures :
  1. glycemic response to the diet [ Time Frame: 8 weeks ]
    change in blood glucose (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.


Secondary Outcome Measures :
  1. Insulin response to the diet [ Time Frame: 8 weeks ]
    change in blood insulin (uU/mL) concentration in response to a meal, from baseline to 8 weeks intervention.

  2. Cholesterol response to the diet [ Time Frame: 8 weeks ]
    change in blood cholesterol (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

  3. Triglyceride response to the diet [ Time Frame: 8 weeks ]
    change in blood triglyceride (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

  4. LDL particle size response to the diet [ Time Frame: 8 weeks ]
    change in LDL particle size (nm) in response to a meal, from baseline to 8 weeks intervention.

  5. hsCRP response to the diet [ Time Frame: 8 weeks ]
    change in hsCRP (mg/L) in response to a meal, from baseline to 8 weeks intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults from 18 - 60 years of age
  • Body mass index between 25 and 40 kg/m2
  • No evidence of diabetes (fasting blood sugar <126 mg/dL).
  • HOMA-IR > 2
  • Willing to consume the study foods and refrain from eating other foods for eight weeks.

Exclusion Criteria:

  • Have type 1 or type 2 diabetes currently being treated by medication.
  • Are being treated with medications that have a significant effect on insulin resistance, obesity, serum lipids, and metabolic rate, or medications that significantly increase body weight such as certain antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators.
  • Current pregnancy or breastfeeding.
  • Women of childbearing potential who are not using an effective method of birth control (i.e., barrier method, intrauterine and cervical devices, oral contraceptives, hormonal injections (Depo Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), are not surgically sterilized (including tubal ligation and hysterectomy), or not at least two years postmenopausal. All women of childbearing potential will have a pregnancy test performed prior to starting the study treatment in each cohort. If a subject becomes pregnant during the study, they will be dropped from the study.
  • Have clinically significant abnormal laboratory markers (as determined by the medical investigator).
  • Have contraindications to participation in a diet intervention.
  • Are unable to provide a baseline blood sample.
  • Have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the foods being tested in the study (determined by the investigative team).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203238


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Alliance for Potato Research and Education
Investigators
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Principal Investigator: John Kirwan, PhD Pennington Biomedical Research Center
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Responsible Party: John Kirwan, Executive Director, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT04203238    
Other Study ID Numbers: 2019-029
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases