Insulin ResistancePREMONCT04203238
Potato Research for Enhancing Metabolic Outcomes
A study testing Reduced Meat High Potato Diet and Reduced Meat High Pulses Diet in people with Insulin Resistance and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- Reduced Meat High Potato Diet and Reduced Meat High Pulses Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 18 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Insulin Resistance, Obesity
- Being tested
- Reduced Meat High Potato Diet, Reduced Meat High Pulses Diet
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Meat High Potato DietOther
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.
Reduced Meat High Pulses DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Potatoes Lean Meat (PLM) | Experimental | 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. Receives: Other: Reduced Meat High Potato Diet |
| Lean Meat Pulses (LMP) | Experimental | 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. Receives: Other: Reduced Meat High Pulses Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start4 Sep 2019
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel design
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Principal investigator, John Kirwan, Pennington Biomedical Research Center
- Investigators
- John Kirwan, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203238
- Sponsor's protocol ID
- PBRC 2019-029
- Acronym
- PREMO
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2019
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36367708
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults
- ClinicalTrials.gov ID
- NCT04203238
- Acronym / sponsor ID
- PREMO / PBRC 2019-029
- Conditions
- Insulin Resistance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel design
| Arm | Type | Receives |
|---|---|---|
| Potatoes Lean Meat (PLM) | Experimental | Other: Reduced Meat High Potato DietThe 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. |
| Lean Meat Pulses (LMP) | Experimental | Other: Reduced Meat High Pulses DietThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced Meat High Potato DietThe 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. | Other | Potatoes Lean Meat (PLM) |
| Reduced Meat High Pulses DietThe 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. | Other | Lean Meat Pulses (LMP) |
Primary outcome
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.
5 secondary outcomes
Insulin Response to the Diet
Time frame: Baseline and 8 weeks
Cholesterol Response to the Diet
Time frame: Baseline and 8 weeks
Triglyceride Response to the Diet
Time frame: Baseline and 8 weeks
LDL Particle Size Response to the Diet
Time frame: Baseline and 8 weeks
hsCRP Response to the Diet
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36367708Rebello 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kirwan, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Meat High Potato Diet and Reduced Meat High Pulses Diet in people with Insulin Resistance and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Response to the Diet (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.