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临床试验/NCT05589467
NCT05589467已完成不适用

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?

Texas Tech University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
weight in lbs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • No diagnosis of type 2 diabetes
  • Group 1 and 2

排除标准

  • 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

结局指标

主要结局

weight in lbs

时间窗: 6 weeks

Weight will be measure to the nearest 0.1 lb

height in centimeters

时间窗: at baseline

Height will be measured to the nearest 0.1 cm using a stadiometer.

Body mass index in kg/m^2

时间窗: at baseline

weight in kg and height in meters will be used to calculate BMI

Systolic and Diastolic blood pressure in mmHg

时间窗: 6 weeks

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.

Waist circumference in inches

时间窗: 6 weeks

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

时间窗: 6 weeks

Body composition (fat and lean body mass) will be measured by bioelectric impedance using a Tanita scale (model SC-331S Tanita, Tokyo, Japan).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shannon Galyean

Assistant Professor/Registered Dietitian Nutritionist

Texas Tech University

研究点 (2)

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