Effects of Potatoes on Blood Pressure in Persons With and Without Type 2 Diabetes Who Follow the DASH Diet for 6 Weeks

NCT05589467 | Completed

• 1 other identifier: IRB2019-880
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Blood Pressure

Keywords

DASH diet

Outcome Measures

Primary Outcomes (14)

• Systolic and Diastolic blood pressure in mmHg

  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.

  at baseline

• Systolic and Diastolic blood pressure in mmHg

  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.

  2 weeks

• Systolic and Diastolic blood pressure in mmHg

  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.

  6 weeks

• Body mass index in kg/m^2

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

  at baseline

• Waist circumference in inches

  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.

  at baseline

• Waist circumference in inches

  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.

  2 weeks

• Waist circumference in inches

  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.

  6 weeks

• body composition in body fat percentage

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

  at baseline

• body composition in body fat percentage

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

  2 weeks

• body composition in body fat percentage

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

  6 weeks

• weight in lbs

  Weight will be measure to the nearest 0.1lb

  at baseline

• weight in lbs

  Weight will be measure to the nearest 0.1 lb

  2 weeks

• weight in lbs

  Weight will be measure to the nearest 0.1 lb

  6 weeks

• height in centimeters

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

  at baseline

Study Arms (3)

DASH Diet and Fried Potatoes

EXPERIMENTAL

DASH-FP (fried potatoes) group

Other: DASH-FP

DASH Diet and Non-Fried Potatoes

EXPERIMENTAL

DASH-NFP (non-fried potatoes) group

Other: DASH-NFP

DASh Diet and No Potatoes

EXPERIMENTAL

DASH-NP (no potatoes) group

Other: Control

Interventions

DASH-FP OTHER

Dash diet with only fried potatoes

DASH Diet and Fried Potatoes

DASH-NFP OTHER

Dash diet with only non-fried potatoes

DASH Diet and Non-Fried Potatoes

Control OTHER

Dash diet with no potatoes

DASh Diet and No Potatoes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (41)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shannon Galyean, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Registered Dietitian Nutritionist

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 21, 2022
• Study Start: January 21, 2020
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)