Type2 DiabetesNCT04511325
Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus
A study testing Potato Regimen and Refined Grain Regimen in people with Type2 Diabetes and Cardiometabolic Syndrome, run by Florida State University at 1 site in United States.
Trial summary
The investigators are examining the effects of potato consumption on indices of glycemic control and cardiovascular health in overweight and obese individuals with type two diabetes mellitus (T2D) to provide feasible and effective dietary ways for individuals to enhance their quality of life. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Type2 Diabetes, Cardiometabolic Syndrome, Arterial Stiffness
- What is being tested?
- Potato Regimen and Refined Grain Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2019to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women
- Overweight or obese individuals (BMI of 25-40 kg/m2),
- Individuals diagnosed type 2 diabetes.
- Individuals considered non-frequent potato consumers (< 2 serving of potatoes a week).
Who cannot join
- Individuals taking insulin
- Individuals diagnosed with CVD
- Individuals with uncontrolled hypertension (≥ 160/100 mmHg)
- Individuals with other active chronic diseases (cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease)
- Women who are pregnant/pre/perimenopausal, or on hormone replacement therapy
- Individuals with fasting blood glucose levels ≥ 200 mg/dL and HbA1c ≥ 9.0 %.
Show all 9Show fewer
- Individuals participating in a weight loss program
- Individuals who are heavy smokers (> 20 cigarettes per day)
- Individuals who are heavy drinkers (> 12 alcoholic drinks per week)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sandels Building, Florida State University
Tallahassee, Florida, 32304
About this study
The investigators are examining the effects of potato consumption on indices of glycemic control and cardiovascular health in overweight and obese individuals with type two diabetes mellitus (T2D) to provide feasible and effective dietary ways for individuals to enhance their quality of life. The overall objective of this crossover study is to collect data regarding the effects of potato consumption on indices of glycemic control and cardiovascular health among overweight and obese individuals with T2D. The central hypothesis of this crossover study is that the daily consumption of 100 g white potato for 12 weeks will contribute to improvements in glycemic control, reductions in inflammation, and improvements in blood lipids and vascular function in overweight and obese individuals with T2D compared to a macronutrient-matched refined grain (75 g cooked long-grain white rice) for 12 weeks (with a 2 week washout period between interventions).
Specific Aim) The assessment of blood glucose control, vascular function, body composition and overall cardiovascular risk after consumption of potatoes (100g/d for 12 weeks) in individuals with T2D compared to a calorie matched refined grain at the initial baseline visit as well as the 6-, and 12-week study visits (for each 12-week intervention period).
Read more
This aim will assess changed in blood glucose, insulin, HbA1c, HOMA-IR, and HOMA-β as well as the following:
- blood pressure (BP)
- markers of endothelial function [flow-mediated dilation (FMD), pulse wave velocity (PWV), and endothelin-1 (ET-1)]
- markers of inflammation (C-reactive protein)
- body composition via bioelectrical impedance (BIA), lean mass and fat mass assessment
- lipid profiles, consisting of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and oxidized LDL (Ox-LDL). Atherogenic risk ratios (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C) will also be assessed
- anthropometrics [weight, height, waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WC/HC)]
Read the detailed description
A total of 50 men and postmenopausal women between the ages of 45 and 80 who have T2D will be recruited for this study. Participants with T2D will be recruited from Tallahassee, FL and surrounding areas through campus and community advertisements through flyers, newspaper articles, and public events. After an initial telephone screening, all participants will be requested to report to the clinical area of the Sandels building at FSU (study site) for their first on-site visit (and all visits if the participant qualifies). On the first visit (screening), the potential participants will be provided with verbal and written explanation of the project and will have any questions regarding the study answered by trained research personnel during the informed consent process. Then the individual will be asked to sign an informed consent form, followed by a medical history questionnaire to confirm their diabetic state, and measurements of their fasting blood glucose levels and HbA1c will also be done to assess any changes that may occur throughout the study. Anthropometrics will be measured and questions on medical history and medication use will be asked during the screening visit to confirm eligibility. Randomization of participants in the potato or the calorie-matched refined grain group will be done after the screening visit and following completion of a Seven-Day Food Frequency Questionnaire (FFQ), which will indicate if individuals frequently consume potatoes. If participants are considered "non-frequent" white potato consumers (<2 servings per week), they will be included in this study and asked to come for following visits, additionally during this visit participants will be familiarized with vascular assessments prior to their baseline appointment. On the second (baseline) visit participants will be randomly assigned to one of two groups: 1) 100 g cooked white potato or 2) 75 g calorie-matched cooked refined grain (cooked long-grain white rice) daily for 12 weeks following a 2-week washout period prior to the other intervention group (a total of 26 weeks upon completion of the study). Study foods will be prepared at the Florida State University Metabolic Kitchen and Diet Assessment Lab following SafeStaff Foodhandler Training, an approved Florida foodhandler program, protocols for preparation, storage and handling. At the baseline visit participants will be asked to come fasted; BP and vascular function will be measured followed by blood draw, anthropometrics, body composition (via BIA), and a physical activity questionnaire will be administered. Participants will be provided with their assigned dietary regimen and will receive instructions on how to fill out daily diaries for their dietary regimen and will be given three-day food records to bring back for their subsequent visits to assess typical intake throughout the study. BP, vascular function, blood draw, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6-, and 12-week visits for both intervention periods with a 2-week washout between each intervention period (for a total of 5 study visits). After the 2-week washout period, participants will be asked to come to the study site, to receive the other intervention group and be given instruction on their new dietary regimen. Participants will be asked to come to the study site on a bi-weekly basis to pick up potato and white rice regimen, which can be stored in the freezer/refrigerator prior to consumption. Additionally, participants will be given portioned cooked rice to take home with them for the long-grain white rice regimen. All cardiovascular measurements will be performed between 7:00-10:00 A.M., in a quiet temperature-controlled room after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.
- Being tested
- Potato Regimen, Refined Grain Regimen
- Keywords
- Functional Foods, Chronic Diseases, Carbohydrates, Endothelial Dysfunction, Cardiometabolic Health
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato RegimenOther
100 grams cooked white russet potato with the skin
Refined Grain RegimenOther
75 grams of cooked long-grain white rice
| Study group | Role | What they receive |
|---|---|---|
| Potato Regimen Arm | Other | All participants will be randomly assigned to receive the potato regimen daily for the 12-week treatment period, separated by a 2-week washout.The potato regimen (75 grams of baked white russet potato with the skin) and refined grain (100 grams of long grain white rice) regimen will be matched for calories, carbohydrate and fat content and will both contribute to approximately 100 kilocalories, 22g carbohydrates, and 0.2g of fat. In order to increase participants' compliance, they will be informed of a variety of ways to consume their regimen. The rationale for choosing this amount of potato and rice regimen is based on the common practice of carbohydrate counting practiced by dietitians and diabetes educators in clinical settings, where 45-60 g of carbohydrates should be consumed at each meal and 15-20 g of carbohydrates can be consumed at each snack throughout the day. Receives: Other: Potato Regimen |
| Refined Grain Regimen Arm | Other | All participants will be randomly assigned to the calorie-matched refined grain daily for the 12-week treatment period, separated by a 2-week washout.The refined grain (100 grams of long grain white rice) regimen will be matched to the potato regimen for calories, carbohydrate and fat content and will both contribute to approximately 100 kilocalories, 22g carbohydrates, and 0.2g of fat. In order to increase participants' compliance, they will be informed of a variety of ways to consume their regimen. The rationale for choosing this amount of potato and rice regimen is based on the common practice of carbohydrate counting practiced by dietitians and diabetes educators in clinical settings, where 45-60 g of carbohydrates should be consumed at each meal and 15-20 g of carbohydrates can be consumed at each snack throughout the day. Long-grain boiled white rice also has a similar glycemic index to that of a baked white potato. Receives: Other: Refined Grain Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on glucose in individuals with type 2 diabetes mellitus.
To examine changes in blood glucose from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on insulin in individuals with type 2 diabetes mellitus.
To examine changes in insulin from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on insulin resistance and insulin sensitivity in individuals with type 2 diabetes mellitus.
To examine changes in HOMA-IR and HOMA-β from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on hemoglobin A1c (HbA1c) in individuals with type 2 diabetes mellitus.
To examine changes in HbA1c from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on lipid profile in individuals with type 2 diabetes mellitus.
To examine changes in total cholesterol (TC), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), oxidized-LDL (Ox-LDL) as well as atherogenic risk ratios (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C), from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on flow-mediated dilation (FMD) in individuals with type 2 diabetes mellitus.
To examine changes in flow-mediated dilation (FMD) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period)on markers on inflammation/adhesion molecules in individuals with type 2 diabetes mellitus.
To examine changes in C-reactive protein and endothelin-1 (ET-1) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on pulse wave velocity (PWV) in individuals with type 2 diabetes mellitus.
To examine changes in pulse wave velocity (PWV) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
Secondary outcomes (3)
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on body composition in individuals with type 2 diabetes mellitus.
To examine changes body composition via biolelectrical impedance (BIA), including lean mass and fat mass from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on BMI in individuals with type 2 diabetes mellitus.
To examine changes in BMI (weight and height) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on waist-to-hip ratio in individuals with type 2 diabetes mellitus.
To examine changes in waist-to-hip ratio (waist and hip circumference) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start27 Apr 2019
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For this randomized cross-over study, participants (45-80 y, BMI 25-35 kg/m2, fasting blood glucose \>126 g/dL, HbA1c 6.5-9%, non-frequent white potato consumption of \<2 servings per week) will be randomly assigned to receive pre-prepared baked white potato (100g cooked with skin; 100kcals) or a calorie-matched refined grain (75g cooked long-grain white rice; control) daily for each or two 12-week treatment periods, separated by a 2-week washout. Randomization of participants in the potato or the calorie-matched refined grain group will be done during the screening visit.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Principal investigator, Neda Akhavan, Florida State University
- Investigators
- Neda S Akhavan, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511325
- Sponsor's protocol ID
- 00000498
- Status last verified
- Sep 2022
- First submitted
- 30 Jul 2020
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data collected in hard copy will be securely stored in a filing cabinet in our laboratory (Sandels 314). The data will only be accessible to the PI by key. De-identified data that is collected in soft copy will be stored on the PI's password protected computer. The data will be linked to subjects via encrypted codes to ensure their protection and confidentiality; the codes will not include HIPPA identifiers, such as initials, date of birth, etc. The encryption code for participants will be kept on the PI's computer; no other staff will have access to the encryption code. All data transferred from computer to computer will only be in the encrypted form. If identifiers are removed from the identifiable private information that are collected during this research, that information or those samples could be used for future research studies or distributed to other investigators for future research studies without additional informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04511325
- Acronym / sponsor ID
- 00000498
- Keywords
- Functional Foods, Chronic Diseases, Carbohydrates, Endothelial Dysfunction, Cardiometabolic Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 27 Apr 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are examining the effects of potato consumption on indices of glycemic control and cardiovascular health in overweight and obese individuals with type two diabetes mellitus (T2D) to provide feasible and effective dietary ways for individuals to enhance their quality of life. The overall objective of this crossover study is to collect data regarding the effects of potato consumption on indices of glycemic control and cardiovascular health among overweight and obese individuals with T2D. The central hypothesis of this crossover study is that the daily consumption of 100 g white potato for 12 weeks will contribute to improvements in glycemic control, reductions in inflammation, and improvements in blood lipids and vascular function in overweight and obese individuals with T2D compared to a macronutrient-matched refined grain (75 g cooked long-grain white rice) for 12 weeks (with a 2 week washout period between interventions).
Specific Aim) The assessment of blood glucose control, vascular function, body composition and overall cardiovascular risk after consumption of potatoes (100g/d for 12 weeks) in individuals with T2D compared to a calorie matched refined grain at the initial baseline visit as well as the 6-, and 12-week study visits (for each 12-week intervention period).
This aim will assess changed in blood glucose, insulin, HbA1c, HOMA-IR, and HOMA-β as well as the following:
- blood pressure (BP)
- markers of endothelial function [flow-mediated dilation (FMD), pulse wave velocity (PWV), and endothelin-1 (ET-1)]
- markers of inflammation (C-reactive protein)
- body composition via bioelectrical impedance (BIA), lean mass and fat mass assessment
- lipid profiles, consisting of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and oxidized LDL (Ox-LDL). Atherogenic risk ratios (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C) will also be assessed
- anthropometrics [weight, height, waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WC/HC)]
Detailed description
A total of 50 men and postmenopausal women between the ages of 45 and 80 who have T2D will be recruited for this study. Participants with T2D will be recruited from Tallahassee, FL and surrounding areas through campus and community advertisements through flyers, newspaper articles, and public events. After an initial telephone screening, all participants will be requested to report to the clinical area of the Sandels building at FSU (study site) for their first on-site visit (and all visits if the participant qualifies). On the first visit (screening), the potential participants will be provided with verbal and written explanation of the project and will have any questions regarding the study answered by trained research personnel during the informed consent process. Then the individual will be asked to sign an informed consent form, followed by a medical history questionnaire to confirm their diabetic state, and measurements of their fasting blood glucose levels and HbA1c will also be done to assess any changes that may occur throughout the study. Anthropometrics will be measured and questions on medical history and medication use will be asked during the screening visit to confirm eligibility. Randomization of participants in the potato or the calorie-matched refined grain group will be done after the screening visit and following completion of a Seven-Day Food Frequency Questionnaire (FFQ), which will indicate if individuals frequently consume potatoes. If participants are considered "non-frequent" white potato consumers (<2 servings per week), they will be included in this study and asked to come for following visits, additionally during this visit participants will be familiarized with vascular assessments prior to their baseline appointment. On the second (baseline) visit participants will be randomly assigned to one of two groups: 1) 100 g cooked white potato or 2) 75 g calorie-matched cooked refined grain (cooked long-grain white rice) daily for 12 weeks following a 2-week washout period prior to the other intervention group (a total of 26 weeks upon completion of the study). Study foods will be prepared at the Florida State University Metabolic Kitchen and Diet Assessment Lab following SafeStaff Foodhandler Training, an approved Florida foodhandler program, protocols for preparation, storage and handling. At the baseline visit participants will be asked to come fasted; BP and vascular function will be measured followed by blood draw, anthropometrics, body composition (via BIA), and a physical activity questionnaire will be administered. Participants will be provided with their assigned dietary regimen and will receive instructions on how to fill out daily diaries for their dietary regimen and will be given three-day food records to bring back for their subsequent visits to assess typical intake throughout the study. BP, vascular function, blood draw, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6-, and 12-week visits for both intervention periods with a 2-week washout between each intervention period (for a total of 5 study visits). After the 2-week washout period, participants will be asked to come to the study site, to receive the other intervention group and be given instruction on their new dietary regimen. Participants will be asked to come to the study site on a bi-weekly basis to pick up potato and white rice regimen, which can be stored in the freezer/refrigerator prior to consumption. Additionally, participants will be given portioned cooked rice to take home with them for the long-grain white rice regimen. All cardiovascular measurements will be performed between 7:00-10:00 A.M., in a quiet temperature-controlled room after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For this randomized cross-over study, participants (45-80 y, BMI 25-35 kg/m2, fasting blood glucose >126 g/dL, HbA1c 6.5-9%, non-frequent white potato consumption of <2 servings per week) will be randomly assigned to receive pre-prepared baked white potato (100g cooked with skin; 100kcals) or a calorie-matched refined grain (75g cooked long-grain white rice; control) daily for each or two 12-week treatment periods, separated by a 2-week washout. Randomization of participants in the potato or the calorie-matched refined grain group will be done during the screening visit.
| Arm | Type | Receives |
|---|---|---|
| Potato Regimen Arm | Other | Other: Potato RegimenAll participants will be randomly assigned to receive the potato regimen daily for the 12-week treatment period, separated by a 2-week washout.The potato regimen (75 grams of baked white russet potato with the skin) and refined grain (100 grams of long grain white rice) regimen will be matched for calories, carbohydrate and fat content and will both contribute to approximately 100 kilocalories, 22g carbohydrates, and 0.2g of fat. In order to increase participants' compliance, they will be informed of a variety of ways to consume their regimen. The rationale for choosing this amount of potato and rice regimen is based on the common practice of carbohydrate counting practiced by dietitians and diabetes educators in clinical settings, where 45-60 g of carbohydrates should be consumed at each meal and 15-20 g of carbohydrates can be consumed at each snack throughout the day. |
| Refined Grain Regimen Arm | Other | Other: Refined Grain RegimenAll participants will be randomly assigned to the calorie-matched refined grain daily for the 12-week treatment period, separated by a 2-week washout.The refined grain (100 grams of long grain white rice) regimen will be matched to the potato regimen for calories, carbohydrate and fat content and will both contribute to approximately 100 kilocalories, 22g carbohydrates, and 0.2g of fat. In order to increase participants' compliance, they will be informed of a variety of ways to consume their regimen. The rationale for choosing this amount of potato and rice regimen is based on the common practice of carbohydrate counting practiced by dietitians and diabetes educators in clinical settings, where 45-60 g of carbohydrates should be consumed at each meal and 15-20 g of carbohydrates can be consumed at each snack throughout the day. Long-grain boiled white rice also has a similar glycemic index to that of a baked white potato. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and postmenopausal women
- Overweight or obese individuals (BMI of 25-40 kg/m2),
- Individuals diagnosed type 2 diabetes.
- Individuals considered non-frequent potato consumers (< 2 serving of potatoes a week).
Key exclusion criteria (9 listed)
- Individuals taking insulin
- Individuals diagnosed with CVD
- Individuals with uncontrolled hypertension (≥ 160/100 mmHg)
- Individuals with other active chronic diseases (cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease)
- Women who are pregnant/pre/perimenopausal, or on hormone replacement therapy
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 |
|---|---|---|
| Potato Regimen100 grams cooked white russet potato with the skin | Other | Potato Regimen Arm |
| Refined Grain Regimen75 grams of cooked long-grain white rice | Other | Refined Grain Regimen Arm |
Primary outcome
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on glucose in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in blood glucose from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on insulin in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in insulin from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on insulin resistance and insulin sensitivity in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in HOMA-IR and HOMA-β from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on hemoglobin A1c (HbA1c) in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in HbA1c from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on lipid profile in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in total cholesterol (TC), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), oxidized-LDL (Ox-LDL) as well as atherogenic risk ratios (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C), from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on flow-mediated dilation (FMD) in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in flow-mediated dilation (FMD) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period)on markers on inflammation/adhesion molecules in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in C-reactive protein and endothelin-1 (ET-1) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on pulse wave velocity (PWV) in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
To examine changes in pulse wave velocity (PWV) from Baseline, 6-week, and 12-week study visits (for each treatment period) in a total of 50 participants.
3 secondary outcomes
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on body composition in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on BMI in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on waist-to-hip ratio in individuals with type 2 diabetes mellitus.
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. All de-identified data collected in hard copy will be securely stored in a filing cabinet in our laboratory (Sandels 314). The data will only be accessible to the PI by key. De-identified data that is collected in soft copy will be stored on the PI's password protected computer. The data will be linked to subjects via encrypted codes to ensure their protection and confidentiality; the codes will not include HIPPA identifiers, such as initials, date of birth, etc. The encryption code for participants will be kept on the PI's computer; no other staff will have access to the encryption code. All data transferred from computer to computer will only be in the encrypted form. If identifiers are removed from the identifiable private information that are collected during this research, that information or those samples could be used for future research studies or distributed to other investigators for future research studies without additional informed consent.
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Neda S Akhavan, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potato Regimen and Refined Grain Regimen in people with Type2 Diabetes and Cardiometabolic Syndrome, run by Florida State University 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 4 inclusion and 9 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 8 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effects of daily white potato versus white rice consumption for 12 weeks (each intervention for 12 weeks with a 2-week washout period) on glucose in individuals with type 2 diabetes mellitus. (time frame: 26 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2022.