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NCT04511325 · ClinicalTrials.gov registry record · NA
Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT04511325 is a NA study that has completed, run by Florida State University. The registered enrollment target is 27 participants.
The verdict
NCT04511325, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study 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 (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: 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 (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C) will also be assessed 6. anthropometrics
Interventions
- OTHER Potato Regimen
- OTHER Refined Grain Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-04-27 |
| Est. Completion | 2022-05-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04511325
The ClinicalTrials.gov registry entry for NCT04511325 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Potato Regimen is the first listed.
NCT04511325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04511325 about?
NCT04511325 is a clinical study titled "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 ov...
What is the current status of trial NCT04511325?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2019-04-27. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT04511325?
The interventions under investigation include: Potato Regimen (OTHER), Refined Grain Regimen (OTHER).
Who is sponsoring clinical trial NCT04511325?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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