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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

T

Texas Tech University

Status

Completed

Conditions

Type 2 Diabetes
Blood Pressure

Treatments

Other: Control
Other: DASH-NFP
Other: DASH-FP

Study type

Interventional

Funder types

Other

Identifiers

NCT05589467
IRB2019-880

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 3 patient groups

DASH Diet and Fried Potatoes
Experimental group
Description:
DASH-FP (fried potatoes) group
Treatment:
Other: DASH-FP
DASH Diet and Non-Fried Potatoes
Experimental group
Description:
DASH-NFP (non-fried potatoes) group
Treatment:
Other: DASH-NFP
DASh Diet and No Potatoes
Experimental group
Description:
DASH-NP (no potatoes) group
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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