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Potato Research for Enhancing Metabolic Outcomes (PREMO)

Primary Purpose

Insulin Resistance, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reduced Meat High Potato Diet

Reduced Meat High Pulses Diet

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Potatoes Lean Meat (PLM)

Lean Meat Pulses (LMP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

glycemic response to the diet

change in blood glucose (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

Secondary Outcome Measures

Insulin response to the diet

change in blood insulin (uU/mL) concentration in response to a meal, from baseline to 8 weeks intervention.

Cholesterol response to the diet

change in blood cholesterol (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

Triglyceride response to the diet

change in blood triglyceride (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

LDL particle size response to the diet

change in LDL particle size (nm) in response to a meal, from baseline to 8 weeks intervention.

hsCRP response to the diet

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

Full Information

NCT ID

NCT04203238

First Posted

August 16, 2019

Last Updated

July 5, 2021

Sponsor

Pennington Biomedical Research Center

Collaborators

Alliance for Potato Research and Education

1. Study Identification

Unique Protocol Identification Number

NCT04203238

Brief Title

Potato Research for Enhancing Metabolic Outcomes

Acronym

PREMO

Official Title

Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 4, 2019 (Actual)

Primary Completion Date

May 18, 2021 (Actual)

Study Completion Date

May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

Alliance for Potato Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized parallel design

Masking

Care ProviderInvestigatorOutcomes Assessor

Masking Description

Investigator and care providers will be blinded to randomization and treatment allocation.

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Potatoes Lean Meat (PLM)

Arm Type

Experimental

Arm Description

Arm Title

Lean Meat Pulses (LMP)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Reduced Meat High Potato Diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Reduced Meat High Pulses Diet

Intervention Description

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 Measure Information:

Title

glycemic response to the diet

Description

change in blood glucose (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Insulin response to the diet

Description

change in blood insulin (uU/mL) concentration in response to a meal, from baseline to 8 weeks intervention.

Time Frame

8 weeks

Title

Cholesterol response to the diet

Description

change in blood cholesterol (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

Time Frame

8 weeks

Title

Triglyceride response to the diet

Description

change in blood triglyceride (mg/dL) concentration in response to a meal, from baseline to 8 weeks intervention.

Time Frame

8 weeks

Title

LDL particle size response to the diet

Description

change in LDL particle size (nm) in response to a meal, from baseline to 8 weeks intervention.

Time Frame

8 weeks

Title

hsCRP response to the diet

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Kirwan, PhD

Organizational Affiliation

Pennington Biomedical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36367708

Citation

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.

Results Reference

derived

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Potato Research for Enhancing Metabolic Outcomes

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