Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults
Phase: NA
Conditions: Insulin Resistance, Obesity
Sponsor: Pennington Biomedical Research Center

 
Date: 09/19/2019 
 
Title: Potato Research for Enhancing Metabolic Outcomes 
 
ClinicalTrials.gov Identifier: NCT04203238 
 

Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults
PI Name: John Kirwan, Ph.D.
Co-Investigator: Candida Rebello, Ph.D., R.D.
Medical Investigator: Frank Greenway, M.D.
Protocol Version Date: September 16, 2019
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ABSTRACT
Background
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. 
Design and Methods
Aim. The aim of the proposed trial is to compare the effect of healthy eating patterns containing 
potato and lean meat (PLM) in the ratio 40:60 + starchy staple (potato), and pulses and lean 
meat (LMP) in the ratio of 40:60 + starchy staple (bread, rice, pasta) for eight weeks on the 
glycemic response, lipid profile, and an inflammatory biomarker (high sensitivity C-reactive 
protein (hsCRP) in 36 overweight or obese, insulin resistant adults. 
Hypothesis. We hypothesize that the PLM and LMP diets will improve blood glucose and lipid 
responses, and hsCRP compared to baseline, and will be non-inferior each other.
Study Design. We propose to conduct a randomized, controlled, parallel trial. Subjects who 
satisfy inclusion/exclusion criteria will report to the Pennington Biomedical Research Center 
(PBRC) in the morning after an overnight fast. Weight and vital signs will be measured and an 
intravenous catheter will be inserted in the arm to obtain baseline blood samples for 
measurement of glucose, insulin, lipids, LDL particle size, and high sensitivity C-reactive protein 
(hsCRP). Subjects will be randomly assigned to receive the PLM or LMP meals and complete a 
meal tolerance test (MTT) measuring glucose and insulin over three hours. 
Following baseline testing, subjects will receive foods each week over eight weeks. All diets will 
be designed to maintain body weight. PLM and LMP diets will include wholegrains, fruits, 
vegetables, nuts, seeds, and five ounces of meat/day with the respective substitutions and 
starchy staples as the main entrées at lunch and dinner. Subjects will be required to eat only the 
study foods and will be counseled by a dietitian on adhering to the study protocol. Subjects will 
report to the PBRC weekly to collect the study foods and will receive nutrition counseling. 
Compliance will be evaluated by the dietitian through monitoring of all foods and containers that 
subjects will be required to return.  Weight and vital signs will be measured weekly. At week 
nine, baseline testing will be repeated and compliance with the diet will be evaluated. Adverse 
events will be recorded during the study. It is our expectation that the approach used in this 
study will provide evidence that in the context of an overall healthy eating pattern, potatoes and 
pulses will reduce the glycemic and insulinemic responses, lipid profile, and hsCRP 
concentration but will be non-inferior to each other.
These results will be significant, in that they will potentially provide a cost-effective intervention 
that will substantially improve the health and quality of life for the growing number of overweight 
or obese individuals who have developed insulin resistance, and prevent or slow the 
progression to diabetes.
DESCRIPTION AND RATIONALE
Insulin Resistance 
The impaired effect of insulin on regulation of blood glucose characterizes the condition known 
as insulin resistance.1 Estimates from the Centers for Disease Control and Prevention suggest 
that more than one in three US adults  (33.9%) have prediabetes,2 an insulin resistant state that 
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places them at high risk for developing diabetes. At the insulin resistant stage, preventive 
treatments are likely to be most effective in individuals at high risk. In similar fashion, guidelines 
for prevention of other chronic diseases such as cardiovascular disease target individuals at risk 
for vascular events. Lifestyle interventions, recommended as the first line of treatment are 
clearly beneficial.3 However, lack of compliance is common in the general population,4-6 and is a 
major shortcoming of lifestyle interventions. Helping people make small sustainable changes 
that confer health benefits constitute the essential components of a long-term strategy to 
prevent chronic disease.
Animal- and Plant-based Dietary Patterns 
Epidemiologic evidence supports an association between meat and animal protein intake and 
increased risk or incidence of type 2 diabetes.7-13 In contrast, plant-based dietary patterns are 
associated with decreased risk or incidence of type 2 diabetes.14,15 However, large-scale 
controlled feeding studies provide a deeper insight into the potential differential effects of plant 
and animal sources of protein than epidemiologic data. The Dietary Approaches to Stop 
Hypertension (DASH) diet and its variations emphasize fruits, vegetables, whole grains, nuts, 
legumes, and seeds.16-18 The Beef in an Optimal Lean Diet (BOLD) was designed to test the 
effects of DASH diet variations that emphasize animal protein, primarily from lean beef. 
Although the DASH diet has a higher ratio of plant to animal protein than a typical American 
diet, it still provides approximately 1.7 times more animal protein than plant protein. The DASH 
diet and its variations demonstrated beneficial effects of increasing plant-based foods on 
cardiovascular risk factors, and vegetarian diets have been shown to improve glycemic 
control.19-21 However, the BOLD study demonstrated that the DASH diet variation incorporating 
lean beef elicited similar cardiovascular benefits as the DASH diet. Thus, the evidence supports 
the inclusion of some animal sources of protein such as lean meats in a plant-based diet to 
reduce the risk of type 2 diabetes and cardiovascular disease.
Potatoes and Food Applications 
The potato is an inexpensive food that comprises approximately 30% of total vegetable intake in 
the United States (US).22  Although primarily defined by their starch content, potatoes are a rich 
source of nutrients and phytochemicals and its starch has unique functionality for food 
applications such as thickening, bulking, and stabilizing.23 Moreover, cooling of gelatinized 
potatoes generates appreciable levels of slowly digested starch and resistant starch (RS) type 
3. Therefore optimizing the preparation of starch-rich potatoes such as boiling, cooling, and 
adding vinegar or small amounts of fat substantially lowers the blood glucose response that 
potatoes elicit.24-27 In addition, potatoes contain high molecular weight amylose, which forms 
insoluble amylose lipid complexes when heated with fatty acids (RS type 5).23 Meat dishes such 
as hamburgers made with all lean meat are dry and particularly lacking in texture. The addition 
of potatoes (prepared to optimize the glycemic response) to a lean meat preparation not only 
reduces the meat and fat content of the diet but also adds moisture to replace the textural 
properties of fat in meat dishes. 
Potatoes and Sustainability 
In the US, per capita meat consumption is approximately three times the global average.28,29 It is 
estimated that by 2050, the demand for livestock products will grow by 70%.30 This scale of 
animal production is detrimental to the environment and a transition towards low-meat diets is 
critical if Western consumers are to shift towards a more sustainable diet.31-33 Based on food 
disappearance data, per capita meat consumption in the US is approximately 10 ounces/day34 
far in excess of federal dietary guidelines (5-6 ounces meat/day).35 
Meat is pleasurable, social, and traditional, which hinders a personal willingness to reduce meat 
in the diet.36 The most promising pathway appears to be one that does not challenge existing 
meal formats and hierarchies in which meat plays a central role but makes an incremental 
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change towards reducing meat in the diet.36,37 Meat substitutes need to be familiar and appeal 
to the senses or other attributes such as value.37 Potato is one of the world’s most popular foods 
providing important nutrients including protein of comparable biological value (90 - 100) to eggs 
(100) without too many calories.38 Meat and potatoes are traditionally grouped together. 
Therefore, using potatoes to expand the concept of meat to encompass non-animal based 
substitutes without affecting the meal portion size is likely to appeal to consumers, and more 
research is needed to explore this possibility. 
Potatoes v. Pulses 
Potatoes have negligible fat and are low in energy density while providing critical nutrients 
especially dietary fiber and potassium designated by the 2015 Dietary Guidelines as being 
“shortfall nutrients,”39 similar to the much acclaimed pulses. The protein content of pulses is 
much higher than potatoes but pulses are low in methionine, tryptophan, and cysteine, which 
makes the biological value of its protein (73) lower than that of potatoes (90-100). Similar to 
potatoes, pulses are inexpensive; however, unlike potatoes the acceptability of pulses is low 
due to perceptions of flatulence, bland taste, and lack of knowledge of cooking techniques.40,41 
Based on national intake estimates, adults in the US consume a mere 0.5 to 1 cup of pulses per 
week.35 Nevertheless, US dietary guidelines and the evidence in the scientific literature 
unequivocally support increased intake of pulses.35,42
Preliminary Data 
Acute studies have demonstrated that ingestion of fat with potato remarkably lowers the blood 
glucose response, without any change or slightly higher insulin concentrations compared to that 
observed after potato ingestion alone.25,26 Similar results were observed with meals consisting 
of lentils and fat.26 Ingestion of potato, meat, fat and additional fiber from a salad lowers the 
blood glucose and insulin response compared to mashed potatoes alone.43 We have previously 
demonstrated in controlled feeding studies that reducing the glycemic load of the diet improves 
insulin sensitivity in obese adults measured using the hyperinsulinemic-euglycemic clamp 
method.44,45  Additionally, epidemiologic evidence supports the addition of potatoes to meat 
dishes to reduce the risk of myocardial infarction.46 
The effect of pulses on the glycemic response has far greater support than potatoes. A 
systematic review and meta-analysis of 41 randomized controlled clinical trials provided 
evidence that pulses as part of a low glycemic index (GI) diet improve glycemic control.47 A 
study conducted in 121 subjects with type 2 diabetes showed that a low GI diet with legumes 
reduced glycated hemoglobin more than a diet high in insoluble fiber from whole wheat 
products.48 Additionally, pulses contain resistant starch which improves insulin sensitivity and 
glucose tolerance.49 Substituting red meat with pulses in a healthy eating plan, improves 
glycemic control.50 Given the similarities between potatoes and pulses, we hypothesize that in 
the context of an overall healthy eating pattern, they are non-inferior to each other.
Summary
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%.51 
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.52 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. Further research in this area is essential in order to find the most 
effective diet regimen for the treatment of insulin resistance in our overweight and obese 
population.
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Hypothesis and Specific Aims
The objective of the present application is to develop a diet intervention to reverse insulin 
resistance in an overweight or obese population. For US adults, the white potato ranks among 
the top 15 foods providing key nutrients such as potassium and dietary fiber.23  Pulses are a 
highly recommended food that contribute as much dietary fiber to the diet of US adults as 
potatoes.53  Our 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. The rationale for the proposed study is that by developing a 
small changes sustainable approach to reducing meat intake and reducing the glycemic load of 
the diet, we can slow and ultimately prevent the progression to diabetes in individuals with 
untreated insulin resistance. We plan to test our hypothesis and accomplish the objective of this 
application by pursuing the following specific aims:
Aim 1. Compare the effect of diets containing white potato/lean meat (PLM) and pulses/lean 
meat (LMP) main entrées for eight weeks on the glycemic response in 36 overweight or obese, 
insulin resistant adults. This aim requires a randomized controlled feeding trial of potato and 
lean meat in the ratio 40:60 + starchy staple (potato), and pulses and lean meat (40:60) + 
starchy staple (bread, rice, pasta). The primary outcome is the glycemic response to the diets. 
Hypothesis. The mean glycemic response will improve compared to baseline in the PLM and 
LMP groups but the two diets will be non-inferior to each other.
Aim 2. Evaluate changes in insulin, total cholesterol, high density lipoprotein cholesterol (HDL) 
low density lipoprotein cholesterol (LDL), triglycerides, LDL particle size, and high sensitivity C-
reactive protein (hsCRP) in response to eating the PLM or LMP diets for eight weeks.
Hypothesis. Blood lipid, insulin, and hsCRP levels will improve, and the LDL particle size will 
increase compared to baseline in the PLM and LMP groups, but the two diets will not differ from 
each other.
RESEARCH DESIGN AND METHODS
The experimental plan is presented in Figure 1.
Study Subjects
This study will enroll 36 overweight or obese male and female subjects. Subjects will be enrolled 
on the basis of the following eligibility criteria:
Inclusion Criteria

Adult from 18 - 60 years of age.

Body mass index (determined at the screening visit) between 25 and 40 kg/m2.

Waist circumference > 35 inches (if female) and 40 inches (if male)

No evidence of diabetes (fasting blood sugar <126 mg/dL).
Figure 1. Study Schema
*Homeostatic model assessment of insulin resistance
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
HOMA-IR > 2.

Willing to consume the study foods and refrain from eating other foods for eight weeks.
Subjects will not be eligible for participation if they meet one or more of the following exclusion 
criteria:
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 tricyclic 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).
Recruitment. Subjects will be recruited through the use of printed material, targeted solicitation 
through the Pennington Biomedical Research Center (PBRC) email listserv and social media. 
Participants will complete an online screening and will be contacted by a PBRC recruiter for a 
brief telephone interview to assess eligibility criteria, prior to being scheduled for a clinic visit. 
Subject eligibility criteria will be evaluated at a single screening visit. The screening visit will 
occur in the outpatient clinic, in the morning following confirmation of an overnight (at least 8 
hours) fast.  Subjects who provide informed consent will proceed with the tests and 
measurements of the screening visit. Subjects who satisfy the eligibility criteria will be enrolled 
in the study. The schedule of assessments is provided in Table 1.
Randomization and Blinding. Subjects will be randomly assigned to one of two groups (n = 18 
per group). Dr. Robbie Beyl, the biostatistician from the PBRC Biostatistics group will be 
responsible for the randomization design, assignment of treatment groups, and statistical 
analyses plans including power and sample size. Except for the Director of the Metabolic 
Kitchen and the dietitian assigned to the study, all other researchers conducting the study will 
be blinded to the treatment group assignment of subjects.
CLINIC VISITS
Subjects will complete one screening visit and nine study visits.
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Procedure
Screening Baseline Visits 2 - 8
Visit 9
Infomed Consent
x
Height/Waist Circumference
x
Weight
x
x
x
x
Vital Signs
x
x
x
Chemistry 15 Panel/CBC
x
x
Insulin 
x
Urine Pregnancy Test**
x
Lipids/LDL Particle Size/hsCRP
x
x
Medical History Questionnaire
x
Adverse Events
x
x
x
Medications
x
Meal Tolerance Test
x
x
Visual Analog Scales (Satiety)
x
x
Study Foods Dispensing
x
x
Compliance 
x
x
Nutrition Counseling
x
x
Table 1. Schedule of Assessments 
*Women of child-bearing potential
Screening Visit (1½ hours)
Subjects will report to Pennington Biomedical in the morning following an overnight fast (except 
for water) that began no later than 8 hours prior to the study appointment. The screening visit 
includes explanation of the study purpose, procedures, and signing of the informed consent. If 
the participant agrees to participate by signing a consent form, the following procedures will be 
performed:

Self-report of personal and family medical history. 

Measurement of height, metabolic weight, waist circumference, vital signs (blood pressure, 
pulse, and temperature).  

Recording of concomitant medication use.

Urine specimen collection for urine human chorionic gonadotropin (HCG) (for pregnancy in 
women of child bearing potential). 

Blood collection for insulin, complete blood count (CBC), and Chemistry 15 panel.  
Baseline (5 hours; fasting for at least 8 hours)
To start the study, eligible subjects will arrive at the clinic in the morning following an overnight 
fast (except for water) that began no later than 8 hours prior to the study appointment. The 
following procedures will be performed:

Measurement of metabolic weight and vital signs (blood pressure, pulse, and temperature).  

Blood collection for measurement of lipids and hsCRP.

Three-hour meal tolerance test (MTT) with glucose and insulin. 

Recording of adverse events. 

Recording of visual analog scale (VAS) ratings of satiety measures

Nutrition counseling session with registered dietitian. 

Dispensation of foods for one week.
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Visits 2 to 4 (1 hour to 1½ hours)
Subjects will report to the clinic and the following procedures will be performed.

Measurement of weight

Collection of all containers, and any uneaten food items and assessment of compliance.

Nutrition counseling session with registered dietitian.

Dispensation of foods for one week.

Recording of adverse events.
Visit 5 (1 hour to 1½ hours; fasting for at least 8 hours)
Subjects will arrive at the clinic in the morning following an overnight fast (except for water) that 
began no later than 8 hours prior to the study appointment. The following procedures will be 
performed:

Measurement of metabolic weight.

Collection of all containers and any uneaten food items and assessment of compliance.

Dispensation of foods for one week. 

Recording of adverse events.
Nutrition counseling session with registered dietitian will be via the telephone. 
Visit 6 - 8 (1 hour to 1½ hours)
Subjects will report to the clinic and the following procedures will be performed.

Measurement of weight 

Collection of all containers and any uneaten food items and assessment of compliance.

Dispensation of foods for one week. 

Recording of adverse events.
Nutrition counseling session with registered dietitian will be via the telephone. 
Visit 9 (4 hours; fasting for at least 8 hours)
Subjects will arrive at the clinic in the morning following an overnight fast (except for water) that 
began no later than 8 hours prior to the study appointment. The following procedures and 
measurements will be performed:

Measurement of metabolic weight and vital signs (blood pressure, pulse, and temperature).  

Blood collection for measurement of CBC, Chemistry 15 panel, LDL particle size, and 
hsCRP.

Three-hour MTT with glucose and insulin. 

Recording of VAS ratings of satiety measures

Recording of adverse events. 
STUDY PROCEDURES
Diets. The main entrée in the PLM and LMP arms will consist of a menu item in which 40% of 
the meat in the original recipe will be replaced with potatoes or pulses, respectively. The diets 
are designed to provide six ounces or less of meat/day which is consistent with the US dietary 
guidelines as well as the DASH diet, and constitutes approximately half the average daily meat 
intake in the US. Potatoes used in the meal preparation will be unpeeled, pre-cooked, 
refrigerated for 12 - 24 hours, and reheated or served cold.
These partially substituted meat dishes will constitute the main entrée at lunch and dinner and 
each dish will be accompanied by a starchy staple consisting of potato (PLM diet) and bread, 
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rice, or pasta (LMP diet). Additionally, the PLM and LMP diets, matched for their carbohydrate 
and dietary fiber content will consist of whole grains, fruits, vegetables (excluding additional 
potatoes and pulses), dairy products, seafood, nuts, and seeds as part of a healthy eating 
pattern. The diets will meet the Institute of Medicine Dietary Reference Intakes 
recommendations of the acceptable macronutrient distribution range for adults.54 Caloric needs 
for weight maintenance will be determined using the Mifflin St. Jeor formula for estimation of 
basal metabolic rate55-57 and multiplied by an activity factor based on subjects’ activity level. All 
foods will be provided to the subjects during the eight week study period. Subjects will report to 
the PBRC each week to collect the foods according to their diet plan. The meals will comprise 
foods that have been prepared in advance and frozen, dry packaged foods, and frozen foods. 
Subjects will be instructed to return all containers and any uneaten food items. The Metabolic 
Kitchen staff will meet with the subject and evaluate compliance.
Nutrition Counseling. Subjects will be counseled on adhering to the diet plan by a PBRC 
dietitian. The PBRC dietitians specialized in counseling have extensive experience in 
advocating behavior change messages to subjects instructed to follow structured meal plans. 
The counseling sessions will be held once per week for 30-60 minutes as needed. For the first 
four weeks, the subjects will meet with the dietitian followed by four weekly sessions over the 
telephone. Counseling sessions will focus on identifying barriers to adhering to the diet plan, 
problem-solving, and how to be compliant on occasions when subjects may have to eat out. 
Meal Tolerance Test (MTT). Following a fast which began no later than eight hours before the 
appointment, an intravenous line will be placed in the arm vein and blood will be drawn for 
baseline (time 0) glucose and insulin measurement, following standard procedures. Subjects will 
then receive the PLM or LMP meal according to the randomization assignment. Blood will be 
collected through the intravenous line at 30, 60, 90, 120, and 180 minutes following the meal for 
measurement of glucose and insulin. 
Biochemical Assessments. Chemistry 15 panel, CBC, fasting insulin, lipid profile, and hsCRP 
measurements will be performed according to standard PBRC procedures for IV line/blood 
draws and the relevant measurement. The LDL particle size will be measured using nuclear 
magnetic resonance (NMR) spectroscopy at LabCorp (Morrisville, NC) in samples collected at 
and shipped from PBRC. 
See Appendix 1 for a detailed listing of all blood draws and their required blood volumes.
Appetite Ratings. A questionnaire (VAS) will be administered at each of the time-points that 
blood is drawn during the meal tolerance test at baseline and at Visit 9. Subjects will be asked 
to rate their appetite by making a mark on the line at the point that best represents their feelings 
at the time that they complete the questionnaire (Appendix 2).
Adverse Events. An Adverse Event (AE) is defined as any untoward medical occurrence in a 
patient or clinical investigation subject, temporally associated with the subject’s participation in 
research. We define AE as any unfavorable and unintended sign (including a clinically 
significant abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the subject’s participation in research.
DATA SAFETY MONITORING PLAN
For each AE, the seriousness, intensity, and relationship to study product will be assessed, 
documented, and supported by an entry in the subject’s medical records. During the study, each 
subject will be carefully monitored for any adverse events. After the initial AE report is 
completed, the investigator is required to follow each subject at subsequent visits/contacts. As 
currently practiced, it is planned that all AEs will be followed in clinic until: 1) resolution; 2) the 
condition stabilizes; 3) the event is otherwise explained; or 4) the subject is lost to follow-up. 
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Additionally, the CBC and Chemistry 15 panel measured at screening and Visit 9 will be 
reviewed by the medical investigator for clinically relevant changes.
Dr. Robbie Beyl will be responsible for all blinding procedures and for subject randomization. 
Except for the Director of the Metabolic Kitchen and the kitchen staff assigned to the study, 
randomization will be blinded to the staff performing the physical measures, metabolic testing, 
performance of assays, entering or calculating data related to the study and study investigators 
to assure minimal potential sources of bias. The randomization envelopes will be maintained in 
a secure location with access limited to authorized personnel. Blinding is critical to the integrity 
of this clinical trial. However, in the event of a medical emergency in an individual subject, in 
which knowledge of the random assignment is critical to the subject’s management, the blind for 
that subject may be broken by the medical investigator of the trial. This will be done by a 
request to the Director of the Metabolic Kitchen to break the blind and report the treatment 
assignment to the medical investigator.
Before breaking the blind of an individual subject’s treatment assignment, the investigator 
should have determined that the information is necessary, i.e., that it will alter the subjects’ 
immediate management. In many cases, particularly when the emergency is clearly not 
investigational product-related, the problem may be properly managed without the need for 
breaking the blind.
In case of an emergency, the investigator may open the emergency randomization envelope to 
reveal the random assignment for that subject. If such breaking of the blind occurs, the 
investigator shall notify the IRB immediately. This information, including the reason for the blind 
being broken must be recorded in the participant chart and regulatory files.
STATISTICAL CONSIDERATIONS
Power and Sample Size. Power for this study is based on a parallel arm design with the 
potato/lean meat diet (PLM) and pulses/lean meat diet (LMP) groups. Equivalence in blood 
glucose will be the primary outcome. A similar crossover study by Hatonen et al.,43 using 11 
subjects, showed that adding meat, fat, and vegetables to a potato meal reduces the 
incremental area under the curve for glucose (iAUC) in a MTT. The iAUC was lower after the 
mixed meal (96 ± 12.5 mmol×min/L) than after potato alone (197 ± 28.2 mmol×min/L). Long 
interventions using crossover designs with washout periods are associated with high dropout 
rates.58 In our experience, recruitment rates are slow and drop-out rates are high, especially, 
when there is no symptomatic improvement that is obvious to subjects participating in the trial. 
Therefore, we will use an eight-week parallel arm design.
We assume the standard deviation estimates from the study by Hatonen et al. to be similar to 
this proposed study since the PLM and LMP daily diets will also reduce the meat content in an 
overall healthy eating pattern which has been shown to lower the glycemic or insulinemic 
responses.50,59,60 Further, our trial is a controlled feeding study in which all meals are provided 
and compliance is tightly monitored by registered dietitians. This study has 80% power to show 
equivalence between the two groups with at least 15 subjects per group given that the 
difference between the two groups is no larger than 40 mmol×min/L. Allowing for approximately 
20% loss to follow-up, or 3 subjects per group, this study will enroll a total of 36 subjects.
Statistical Analysis. The secondary outcomes are changes in insulin, lipid concentrations, LDL 
particle size, and hsCRP. Mixed effect linear models will all be used to estimate changes across 
the eight weeks for primary and secondary outcomes. Normality of model residuals will be 
checked and transformation will be applied where necessary. An unstructured covariance matrix 
will model the within-subject effects. Missing data is assessed using a sensitivity analyses which 
will use several different sets of models under different assumptions. Covariates, like age, race, 
and gender will be determined using Akaike information criterion (AIC) as the model fit criteria.  
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Continuous covariate effect will be expressed as partial correlations while categorical effects will 
be expressed as differences between least square means. 
DATA COLLECTION AND QUALITY ASSUARANCE
The only people who will know that these patients are research participants are members of the 
research team.  No information about them, or provided by them during the research, will be 
disclosed to others without their written permission, except if it is necessary to protect their 
rights or welfare (for example, in case of injury or emergency care), or if it is required by law.  
When the results of the research are published or discussed in conferences, no information will 
be included that would reveal the identity of these patients.  All data will be kept in secure files, 
and subjects will be identified by codes when the data gathered in this procedure is presented 
or published.  Authorized representatives of the sponsor may need to review records of 
individual participants.  As a result, they may see their name; but they are bound by rules of 
confidentiality not to reveal the patients’ identity to others. 
Privacy
The subjects will be interviewed in the privacy of an exam room and their records will be 
protected by a secure medical records area and a password-protected electronic database 
monitored by the Pennington Research Computing group. Subjects will be asked to sign a 
written consent after reading it, having it reviewed with them by the study staff, and having all 
their questions answered.  The consent conversation will be conducted in the privacy of an 
exam room and the subject will be allowed to take the consent home to discuss their decision 
with their family or counselor, if desired. Study procedures will be conducted by trained staff in 
accordance with PBRC outpatient and inpatient clinic standards of practice and with subjects’ 
informed consent. Confidential subject information including medical records and test results will 
be available only to persons authorized by PBRC. Information collected from subjects will be the 
minimum amount of data necessary to accomplish the research purposes.
Data and Specimen Management
Study participants will be assigned unique subject identification (ID) numbers.  Study subject ID 
numbers will be used on all data collection instruments, to include questionnaires, data 
collection forms, biological specimen tubes, and computer records.  A master list linking the 
participants’ names and ID numbers will be kept in a password-protected computer file with 
access restricted to the PI, Co-PI and medical investigator.  Biological samples that are moved 
off-site for analysis will not contain any personally identifiable information and will be labeled 
with only the unique subject ID numbers.  Staff at these sites will not have access to the master 
list at any time.
Data collection forms will be kept secure, or password-protected if computerized, and under the 
control of the PI, Co-PI, and medical investigator.  Only personnel assigned to the research 
study by the PI will have access to the data.  Hard-copy data records will be stored for a 
minimum of 3 years.
The PBRC has a fully integrated, campus-wide, automated data management system. All data 
are entered into a central database using existing methodology that has been fully validated. All 
data are backed up daily, and the Research Computing Core at the PBRC oversees all data 
management. The research team has extensive experience using the procedures and methods 
required to conduct this study. Standard operating procedures in place throughout the units at 
PBRC will be utilized for repeatable, valid data collection and quality.  
In accordance the standards of practice followed by the Clinical Chemistry core, blood samples 
will be stored frozen at PBRC until analysis can be completed. Specific blood samples will be 
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shipped to LabCorp (Morrisville, NC) for analysis of LDL particle size. Packaging and shipping 
of biological samples will be overseen by the Co-PI, shipped by the laboratory and will be 
completed in accordance with International Air Transport Association regulations to ensure that 
viable biological samples reach their intended destination. 
 
WITHDRAWAL OF SUBJECTS
We will attempt to retain program participants once randomized for study completion through 
the end of study visit. It is our desire to analyze results on all participants who were enrolled in 
the study. In accordance with the declaration of Helsinki/Tokyo/Venice/Hong Kong, participants 
have the right to withdraw from the program at any time for any reason. The investigator also 
has the right to withdraw participants from the program treatments in the event of inter-current 
illness, adverse experience, treatment failure, protocol violation, or other reasons. Should a 
participant decide to withdraw from treatment, all efforts will be made to complete and report 
follow-up observations as thoroughly as possible. 
RISKS/BENEFITS
The study involves the following risks:

IV Procedures/Blood Draws: There is the possibility of discomfort, pain, and bruising at the 
vein on the arm where the needle is inserted. There may also be a small risk of bleeding 
and a very small risk of infection at the site of the blood draw.  Sterile technique and trained 
personnel minimize these risks.

Study Foods. The meals provided during the study are foods that are ordinarily consumed 
by people and are cooked and stored using methods common in food preparation. The 
research dietitians and staff of the research kitchen are experienced in developing, 
preparing, storing, and dispensing study-specific food products developed to meet the 
needs of the study. Additionally, subjects will be asked to inform staff about any food 
allergies or intolerances. A dietary questionnaire is routinely administered at the screening 
visit when the study involves a meal service. Research dietitians are responsible for 
managing the dietary component of specific study protocols. A continuous quality assurance 
program is followed to check food item weights, recipe procedures, packaging of meals, and 
food temperatures.  Documentation is  maintained for each study. All Metabolic Kitchen staff 
members receive training in food sanitation and in research diet preparation. Therefore, 
there is no risk associated with the meals provided by the Pennington Metabolic kitchen.

Nutrition Counseling.  There is minimal risk associated with behavioral counseling.  
Sessions are confidential and the counselor is trained to minimize any discomfort that is 
associated with the discussions during the sessions. 

Medical History Questionnaire: Subjects may refrain from answering questions if they do 
not wish to do so. There are no risks from completing the questionnaire.

Anthropometric Measurements and Vital Signs. The PBRC outpatient and inpatient clinic 
staff are trained to perform these procedures in accordance with PBRC standards of 
practice. There are no risks involved. 

Urine Test. The staff of the phlebotomy unit collect the urine in accordance with standard 
operating practices. There are no risks involved.
In addition to the risks listed above, participants may experience a previously unknown risk or 
side effect.
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Minimizing risks
Continuous monitoring by the Co-PI and/or the medical investigator of the study will minimize all 
potential risks and discomforts.  Research participants will be immediately withdrawn from the 
study if participation in the study becomes an unreasonable risk to the subject.
Potential Benefits to Subjects
Based on the preliminary data, there is high likelihood that subjects may have improvements in 
the biochemical measures evaluated in the study. Subjects will gain knowledge of effective diet 
prescriptions for improvements in metabolic health. Since the changes are small, it is expected 
that subjects will be able to sustain these lifestyle changes over the long term.
PAYMENT FOR PARTICIPATION 
At the completion of all study visits and procedures, participants will be paid $200 for the time 
spent in the clinic. Subjects will receive $75 for the Baseline visit and $125 for Visit 9.This 
compensation is in line with all the other studies conducted at the Pennington Biomedical 
Research Center. 
EMERGENCY CARE AND COMPENSATION FOR RESEARCH-RELATED INJURY
No form of compensation for medical treatment is available from the Pennington Biomedical 
Research Center.  In the event of injury or medical illness resulting from the research 
procedures the research volunteer (from any group) will be referred to their physician/surgeon 
or a treatment facility.  The Pennington Biomedical Research Center is a research facility and 
provides medical treatment only as part of research protocols.  Should a volunteer require 
medical treatments, community physicians and hospitals must provide them to him/her.  
SHARING OF RESULTS WITH SUBJECTS 
The screening lab results will be shared with the subjects on their first testing visit. At the end of 
the study, a manuscript will be prepared for submission to a peer-reviewed journal. A summary 
of the results will be posted on ClinicalTrials.gov which subjects may access.
RESOURCES AVAILABLE 
The Outpatient and Inpatient research units and the Metabolic Kitchen are well equipped and 
staffed to carry out the requirements of this study and appropriate standards of practice are in 
place to ensure appropriate research procedures.
ECONOMIC BURDEN TO SUBJECTS 
There are no costs for which the subjects will be responsible. 
CONSENT PROCESS 
Written informed consent will be obtained in the outpatient research clinic by the coordinators 
and one of the physicians will be available to answer questions if needed. A waiting period will 
be allowed, if desired by the participant. The coordinators and investigators will be available for 
questions throughout the study.
SIGNIFICANCE OF THE STUDY 
Insulin resistance is a hallmark of obesity and lies along the continuum of type 2 diabetes which 
remarkably affects 9.4% of the US population.2 The debilitating complications of diabetes 
include heart disease, stroke, amputations, end-stage renal disease, and blindness. Thus, 
research that focuses on preventing diabetes, and finding a treatment that is cost efficient is 
important. Potatoes are recognized as a starch-rich vegetable and denigrated for their role in 
contributing to obesity and diabetes, regardless of how they are prepared. However, potatoes 
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are a low-cost source of critical nutrients, high-quality protein, and phytochemicals which are 
largely ignored. Given their frequency of consumption, potatoes are clearly available, familiar, 
and taste good, which gives them an unassailable edge over other plant foods as a means of 
cutting the meat in a dish. Our randomized controlled feeding study will be the first trial to test 
this deceptively simple strategy to enhance the overall quality of the diet and provide health 
benefits. More importantly, these small changes are likely to be sustained over time Further, we 
expect that the potato will hold its own in a fair comparison with pulses, a food that is frequently 
promoted for its health benefits.
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APPENDIX 1
Screening  Baseline 
Visit 9 
Blood (ml) Blood (ml)
Blood (ml)
CBC 
4
4
Chemistry 15/Insulin 
4
4
Lipids 
4.5
LDL particle size 
1.5
1.5
Glucose and Insulin (MTT)
15
12.5
Total
8
21
22
Test
Notes: (1) Chemistry 15 includes fasting glucose and lipids (2) IV 
blood draw volumes include 0.5 ml returned during blood draw.
Table 1. Volume of blood drawn at Screening, Baseline, 
and Visit 9
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Appendix 2.
Appetite Ratings
How hungry are you?
Not at all
Extremely
How full are you?
Not at all
Extremely
How strong is your desire to eat?
Extremely 
low
Extremely 
high
How much do you think you could eat right now?
Nothing 
at all
A very 
large 
amount
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