- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511325
Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus
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)]
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Tallahassee, Florida, United States, 32304
- Sandels Building, Florida State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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 %.
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Potato Regimen Arm
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.
|
100 grams cooked white russet potato with the skin
|
OTHER: Refined Grain Regimen Arm
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.
|
75 grams of cooked long-grain white rice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
26 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Neda S Akhavan, PhD, Florida State University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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