Clinical trial NCT05589467: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Blood Pressure
Keywords: DASH diet
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Alliance for Potato Research and Education
First posted: 2022-10-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Systolic and Diastolic blood pressure in mmHg
timeFrame: at baseline
measure: Systolic and Diastolic blood pressure in mmHg
timeFrame: 2 weeks
measure: Systolic and Diastolic blood pressure in mmHg
timeFrame: 6 weeks
measure: Body mass index in kg/m^2
timeFrame: at baseline
measure: Waist circumference in inches
timeFrame: at baseline
measure: Waist circumference in inches
timeFrame: 2 weeks
measure: Waist circumference in inches
timeFrame: 6 weeks
measure: body composition in body fat percentage
timeFrame: at baseline
measure: body composition in body fat percentage
timeFrame: 2 weeks
measure: body composition in body fat percentage
timeFrame: 6 weeks
measure: weight in lbs
timeFrame: at baseline
measure: weight in lbs
timeFrame: 2 weeks
measure: weight in lbs
timeFrame: 6 weeks
measure: height in centimeters
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: Texas Tech University
name: Shannon Galyean, PhD
role: PRINCIPAL_INVESTIGATOR
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