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

Type 2 Diabetes Clinical Trial

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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05589467
• Other study ID #: IRB2019-880
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2023
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• DASH-FP
Dash diet with only fried potatoes
• DASH-NFP
Dash diet with only non-fried potatoes
• Control
Dash diet with no potatoes

Locations

Country	Name	City	State
United States	Texas Tech University	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	Alliance for Potato Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline
Primary	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.	2 weeks
Primary	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.	6 weeks
Primary	Body mass index in kg/m^2	weight in kg and height in meters will be used to calculate BMI	at baseline
Primary	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.	at baseline
Primary	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.	2 weeks
Primary	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.	6 weeks
Primary	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).	at baseline
Primary	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).	2 weeks
Primary	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).	6 weeks
Primary	weight in lbs	Weight will be measure to the nearest 0.1lb	at baseline
Primary	weight in lbs	Weight will be measure to the nearest 0.1 lb	2 weeks
Primary	weight in lbs	Weight will be measure to the nearest 0.1 lb	6 weeks
Primary	height in centimeters	Height will be measured to the nearest 0.1 cm using a stadiometer.	at baseline