PREMO: Potato Research for Enhancing Metabolic Outcomes

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT04203238
Collaborator
Alliance for Potato Research and Education (Other)
36
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20.4
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Study Details

Study Description

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
  • Other: Reduced Meat High Potato Diet
  • Other: Reduced Meat High Pulses Diet
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized parallel designRandomized 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 :
Sep 4, 2019
Actual Primary Completion Date :
May 18, 2021
Actual Study Completion Date :
May 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. glycemic response to the diet [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 [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 [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 [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 [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 [8 weeks]

    change in hsCRP (mg/L) in response to a meal, from baseline to 8 weeks intervention.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

Sponsors and Collaborators

  • Pennington Biomedical Research Center
  • Alliance for Potato Research and Education

Investigators

  • Principal Investigator: John Kirwan, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Kirwan, Executive Director, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT04203238
Other Study ID Numbers:
  • 2019-029
First Posted:
Dec 18, 2019
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2021