Effects of Potatoes on Blood Pressure in Persons With and Without Type 2 Diabetes Who Follow the DASH Diet for 6 Weeks
NCT ID: NCT05589467
Last Updated: 2024-07-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
26 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-01-21
Study Completion Date
2022-10-13
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Type 2 Diabetes
Blood Pressure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
SINGLE
Participants
Study Groups
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DASH Diet and Fried Potatoes
DASH-FP (fried potatoes) group
Group Type
EXPERIMENTAL
DASH-FP
Intervention Type
OTHER
Dash diet with only fried potatoes
DASH Diet and Non-Fried Potatoes
DASH-NFP (non-fried potatoes) group
Group Type
EXPERIMENTAL
DASH-NFP
Intervention Type
OTHER
Dash diet with only non-fried potatoes
DASh Diet and No Potatoes
DASH-NP (no potatoes) group
Group Type
EXPERIMENTAL
Control
Intervention Type
OTHER
Dash diet with no potatoes
Interventions
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DASH-FP
Dash diet with only fried potatoes
Intervention Type
OTHER
DASH-NFP
Dash diet with only non-fried potatoes
Intervention Type
OTHER
Control
Dash diet with no potatoes
Intervention Type
OTHER
Eligibility Criteria
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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
-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
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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Alliance for Potato Research and Education
OTHER
Sponsor Role
collaborator
Texas Tech University
OTHER
Sponsor Role
lead
Responsible Party
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Shannon Galyean
Assistant Professor/Registered Dietitian Nutritionist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Shannon Galyean, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University
Locations
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Texas Tech University
Lubbock, Texas, United States
Site Status
Countries
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United States
References
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Other Identifiers
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IRB2019-880
Identifier Type: -
Identifier Source: org_study_id
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