Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus

NCT04511325 | Completed

• 1 other identifier: 00000498
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 (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. 1.blood pressure (BP)
2. 2.markers of endothelial function \[flow-mediated dilation (FMD), pulse wave velocity (PWV), and endothelin-1 (ET-1)\]
3. 3.markers of inflammation (C-reactive protein)
4. 4.body composition via bioelectrical impedance (BIA), lean mass and fat mass assessment
5. 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. 6.anthropometrics \[weight, height, waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WC/HC)\]

Conditions

Type2 Diabetes; Cardiometabolic Syndrome; Arterial Stiffness; Overweight and Obesity

Keywords

Functional Foods; Chronic Diseases; Carbohydrates; Endothelial Dysfunction; Cardiometabolic Health

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  26 weeks

Study Arms (2)

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.

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.

Other: Refined Grain Regimen

Interventions

Potato Regimen OTHER

100 grams cooked white russet potato with the skin

Potato Regimen Arm

Refined Grain Regimen OTHER

75 grams of cooked long-grain white rice

Refined Grain Regimen Arm

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Sandels Building, Florida State University

Tallahassee, Florida, 32304, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Neda S Akhavan, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Neda S. Akhavan

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 13, 2020
• Study Start: April 27, 2019
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data collection will be available once the participant has come in for their study visit and will be available for up to 10 years since the study has began unless otherwise extended.
• Access Criteria: Only CITI trained and FSU trained research personnel will have access to data for the study following all University IRB guidelines. Research staff will be trained on the importance of participant confidentiality. Efforts will be made to limit the use and disclosure of personal information, including research study and medical records, to people who need to review this information. Data will be stored on the PI's password protected computer. Data will be stored until all analyses and reports are completed. Upon completion, data will be moved to the PI's password-protected computer for long-term storage. The PI will be responsible for the transmission of the data. Data will be transported using a flash drive, designated only for research purposes.

Locations

US (1)