Blood Pressure, Type 2 Diabetes
Conditions
Keywords
DASH diet
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.
Interventions
OTHERDASH-NFP
Dash diet with only non-fried potatoes
OTHERControl
Dash diet with no potatoes
OTHERDASH-FP
Dash diet with only fried potatoes
Sponsors
Alliance for Potato Research and Education
Texas Tech University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and Diastolic blood pressure in mmHg | at baseline | 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 | at baseline | weight in kg and height in meters will be used to calculate BMI |
| Waist circumference in inches | at baseline | 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 | at baseline | 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 | at baseline | Weight will be measure to the nearest 0.1lb |
| height in centimeters | at baseline | Height will be measured to the nearest 0.1 cm using a stadiometer. |
Countries
United States
Outcome results
None listed