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Completed

NCT Number: NCT05589467

Effects of Potatoes on Blood Pressure in Persons With and Without Type 2 Diabetes Who Follow the DASH Diet for 6 Weeks

This study will be a randomized controlled intervention study that will collect pre-intervention and post-intervention anthropometric health data of men and women aged 18-65 years who have type 2 diabetes and who do not have type 2 diabetes. The information collected will be analyzed and used to compare to the post intervention. 12 participants who have type 2 diabetes and 12 participants who do not have type 2 diabetes will be randomized into either the DASH-FP (fried potatoes), DASH-NFP (non-fried potatoes) or DASH-NP (no potatoes) groups, stratifying by sex (male or female) and age range (18 to less than 35, 35 to less than 66 years old) in blocks of three.

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Key information

Conditions

Type 2 Diabetes Blood Pressure Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University

Lubbock, Texas, 79409, United States

About this study

Subjects will follow the DASH diet for 2 weeks to establish baseline blood pressure and then will be randomized to a 4-week intervention study with assigned dietary patterns (DASH-NP as a control diet, DASH-FP diet with only fried potatoes, or DASH-NFP diet with only non-fried potatoes) in accordance with the protocol given above. Before intervention, each group will receive a cooking demonstrations, samples, and recipes to show the correct preparation method and seasoning ingredient to use according to each treatment group. The control group will receive a cooking demonstration including DASH diet recipes without potatoes. Potatoes will be provided for participants in the potato groups allowing for one serving a day of potatoes prepared according to their treatment group.

The control diet will be the standard DASH diet but with no potatoes. DASH-FP will include 5 servings of fried potatoes each week. DASH-NFP will include 5 servings of non-fried potatoes each week. Participants will be instructed to maintain the broad requirements of the DASH diet on their own. A 7-day menu cycle from the DASH-Sodium study for each dietary pattern at different energy levels will be used as the basis for the recommended diets. There will be weekly contact with the participants in which the DASH diet will be reinforced. The goal of the weekly sessions will be to assist participants in learning how to buy and prepare the appropriate foods according to their dietary pattern, to enhance their motivation to choose to eat those foods, and to overcome obstacles to following the diet.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1:

-Well controlled type 2 diabetes as diagnosed by a physician, which is managed by diet and exercise alone or any diabetes medication(s) other than insulin; clinically stable.

Group 2:

-No diagnosis of type 2 diabetes

Group 1 and 2 Exclusion Criteria:

  • Use of tobacco
  • Self-reported history of chronic diseases other than type 2 diabetes (e.g., cardiovascular, etc.)
  • Evidence of severe diabetic complications (such as proliferative retinopathy or diabetic nephropathy)
  • Uncontrolled hypertension
  • Use of oral steroids, hormone replacement therapy
  • Individuals with blood pressure ≥160/100, or HbA1c ≥9%
  • Individuals with allergy to potatoes
  • Pregnant or lactating
  • Individuals on insulin therapy
  • Any alcohol or drug dependence

Treatment and study plan

DASH-FP

Other

Dash diet with only fried potatoes

DASH-NFP

Other

Dash diet with only non-fried potatoes

Control

Other

Dash diet with no potatoes

Primary outcomes

  1. Systolic and Diastolic blood pressure in mmHg

    Time frame: at baseline

    After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken, using an Omron IntelliSense® Blood Pressure Monitor using an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals and the average of the three measurements used.

  2. Systolic and Diastolic blood pressure in mmHg

    Time frame: 2 weeks

    After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken, using an Omron IntelliSense® Blood Pressure Monitor using an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals and the average of the three measurements used.

  3. Systolic and Diastolic blood pressure in mmHg

    Time frame: 6 weeks

    After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken, using an Omron IntelliSense® Blood Pressure Monitor using an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals and the average of the three measurements used.

  4. Body mass index in kg/m^2

    Time frame: at baseline

    weight in kg and height in meters will be used to calculate BMI

  5. Waist circumference in inches

    Time frame: at baseline

    A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (mid-way between the 10th rib and the ileac crest) as recommended by the World Health Organization and hip circumference over the widest point over the buttocks to the nearest centimeter.

  6. Waist circumference in inches

    Time frame: 2 weeks

    A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (mid-way between the 10th rib and the ileac crest) as recommended by the World Health Organization and hip circumference over the widest point over the buttocks to the nearest centimeter.

  7. Waist circumference in inches

    Time frame: 6 weeks

    A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (mid-way between the 10th rib and the ileac crest) as recommended by the World Health Organization and hip circumference over the widest point over the buttocks to the nearest centimeter.

  8. body composition in body fat percentage

    Time frame: at baseline

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).

  9. body composition in body fat percentage

    Time frame: 2 weeks

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).

  10. body composition in body fat percentage

    Time frame: 6 weeks

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).

  11. weight in lbs

    Time frame: at baseline

    Weight will be measure to the nearest 0.1lb

  12. weight in lbs

    Time frame: 2 weeks

    Weight will be measure to the nearest 0.1 lb

  13. weight in lbs

    Time frame: 6 weeks

    Weight will be measure to the nearest 0.1 lb

  14. height in centimeters

    Time frame: at baseline

    Height will be measured to the nearest 0.1 cm using a stadiometer.

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • Alliance for Potato Research and Education

Registry information

Official study title

What Are the Effects of Potatoes, Utilizing Specific Cooking Methods, on Blood Pressure in Hypertensive Persons With and Without Type II Diabetes Who Follow the DASH Diet for 6 Weeks?

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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