- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203238
Potato Research for Enhancing Metabolic Outcomes (PREMO)
November 1, 2023 updated by: John Kirwan, Pennington Biomedical Research Center
Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Response to the Diet
Time Frame: Baseline and 8 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Response to the Diet
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
change in hsCRP (mg/L) in response to the diet.
Positive values are considered a worse outcome.
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John Kirwan, PhD, Pennington Biomedical Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2019
Primary Completion (Actual)
May 18, 2021
Study Completion (Actual)
May 18, 2021
Study Registration Dates
First Submitted
August 16, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 18, 2019
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2019-029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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