Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511325
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2020-07-30
Brief Title:
Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus
Sponsor:
Florida State University
Organization:
Florida State University
Study Overview
Official Title:
Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 100gd 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
1 blood pressure BP
2 markers of endothelial function flow-mediated dilation FMD pulse wave velocity PWV and endothelin-1 ET-1
3 markers of inflammation C-reactive protein
4 body composition via bioelectrical impedance BIA lean mass and fat mass assessment
5 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 TCHDL-C LDL-CHDL-C HDL-CLDL-C will also be assessed
6 anthropometrics weight height waist circumference WC hip circumference HC waist-to-hip ratio WCHC
Specific Aim The assessment of blood glucose control vascular function body composition and overall cardiovascular risk after consumption of potatoes 100gd 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
1 blood pressure BP
2 markers of endothelial function flow-mediated dilation FMD pulse wave velocity PWV and endothelin-1 ET-1
3 markers of inflammation C-reactive protein
4 body composition via bioelectrical impedance BIA lean mass and fat mass assessment
5 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 TCHDL-C LDL-CHDL-C HDL-CLDL-C will also be assessed
6 anthropometrics weight height waist circumference WC hip circumference HC waist-to-hip ratio WCHC
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 freezerrefrigerator 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 700-1000 AM in a quiet temperature-controlled room after an overnight fast and 12 hours after the abstinence of caffeine andor 24 hours after the last bout of moderate to heavy physical activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None