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

Primary Purpose

Type 2 Diabetes, Blood Pressure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH-FP
DASH-NFP
Control
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes focused on measuring DASH diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Tech University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

DASH Diet and Fried Potatoes

DASH Diet and Non-Fried Potatoes

DASh Diet and No Potatoes

Arm Description

DASH-FP (fried potatoes) group

DASH-NFP (non-fried potatoes) group

DASH-NP (no potatoes) group

Outcomes

Primary Outcome Measures

Systolic and Diastolic blood pressure in mmHg
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.
Systolic and Diastolic blood pressure in mmHg
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.
Systolic and Diastolic blood pressure in mmHg
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.
Body mass index in kg/m^2
weight in kg and height in meters will be used to calculate BMI
Waist circumference in inches
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.
Waist circumference in inches
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.
Waist circumference in inches
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.
body composition in body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).
body composition in body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).
body composition in body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).
weight in lbs
Weight will be measure to the nearest 0.1lb
weight in lbs
Weight will be measure to the nearest 0.1 lb
weight in lbs
Weight will be measure to the nearest 0.1 lb
height in centimeters
Height will be measured to the nearest 0.1 cm using a stadiometer.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2022
Last Updated
February 20, 2023
Sponsor
Texas Tech University
Collaborators
Alliance for Potato Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT05589467
Brief Title
Effects of Potatoes on Blood Pressure in Persons With and Without Type 2 Diabetes Who Follow the DASH Diet for 6 Weeks
Official 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?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University
Collaborators
Alliance for Potato Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Blood Pressure
Keywords
DASH diet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DASH Diet and Fried Potatoes
Arm Type
Experimental
Arm Description
DASH-FP (fried potatoes) group
Arm Title
DASH Diet and Non-Fried Potatoes
Arm Type
Experimental
Arm Description
DASH-NFP (non-fried potatoes) group
Arm Title
DASh Diet and No Potatoes
Arm Type
Experimental
Arm Description
DASH-NP (no potatoes) group
Intervention Type
Other
Intervention Name(s)
DASH-FP
Intervention Description
Dash diet with only fried potatoes
Intervention Type
Other
Intervention Name(s)
DASH-NFP
Intervention Description
Dash diet with only non-fried potatoes
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Dash diet with no potatoes
Primary Outcome Measure Information:
Title
Systolic and Diastolic blood pressure in mmHg
Description
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.
Time Frame
at baseline
Title
Systolic and Diastolic blood pressure in mmHg
Description
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.
Time Frame
2 weeks
Title
Systolic and Diastolic blood pressure in mmHg
Description
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.
Time Frame
6 weeks
Title
Body mass index in kg/m^2
Description
weight in kg and height in meters will be used to calculate BMI
Time Frame
at baseline
Title
Waist circumference in inches
Description
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.
Time Frame
at baseline
Title
Waist circumference in inches
Description
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.
Time Frame
2 weeks
Title
Waist circumference in inches
Description
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.
Time Frame
6 weeks
Title
body composition in body fat percentage
Description
Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).
Time Frame
at baseline
Title
body composition in body fat percentage
Description
Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).
Time Frame
2 weeks
Title
body composition in body fat percentage
Description
Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).
Time Frame
6 weeks
Title
weight in lbs
Description
Weight will be measure to the nearest 0.1lb
Time Frame
at baseline
Title
weight in lbs
Description
Weight will be measure to the nearest 0.1 lb
Time Frame
2 weeks
Title
weight in lbs
Description
Weight will be measure to the nearest 0.1 lb
Time Frame
6 weeks
Title
height in centimeters
Description
Height will be measured to the nearest 0.1 cm using a stadiometer.
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Galyean, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Potatoes on Blood Pressure in Persons With and Without Type 2 Diabetes Who Follow the DASH Diet for 6 Weeks

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