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Type 2 DiabetesNCT05589467

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

A study testing DASH-FP and DASH-NFP in people with Type 2 Diabetes and Blood Pressure, run by Texas Tech University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes, Blood Pressure
What is being tested?
DASH-FP and DASH-NFP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
21 Jan 2020to 13 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Tech University

    Lubbock, Texas, 79409

Other trials in United States

About this study

Official title: 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?

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.

Read the 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.

Being tested
DASH-FP, DASH-NFP, Control
Keywords
DASH diet
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DASH-FPOther

    Dash diet with only fried potatoes

  • DASH-NFPOther

    Dash diet with only non-fried potatoes

  • ControlOther

    Dash diet with no potatoes

Study groups in NCT05589467
Study groupRoleWhat they receive
DASH Diet and Fried PotatoesExperimentalDASH-FP (fried potatoes) group
Receives: Other: DASH-FP
DASH Diet and Non-Fried PotatoesExperimentalDASH-NFP (non-fried potatoes) group
Receives: Other: DASH-NFP
DASh Diet and No PotatoesExperimentalDASH-NP (no potatoes) group
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at baseline

  2. 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.

    Measured: 2 weeks

  3. 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.

    Measured: 6 weeks

  4. Body mass index in kg/m^2

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

    Measured: at baseline

  5. 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.

    Measured: at baseline

  6. 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.

    Measured: 2 weeks

  7. 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.

    Measured: 6 weeks

  8. 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).

    Measured: at baseline

  9. 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).

    Measured: 2 weeks

  10. 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).

    Measured: 6 weeks

  11. weight in lbs

    Weight will be measure to the nearest 0.1lb

    Measured: at baseline

  12. weight in lbs

    Weight will be measure to the nearest 0.1 lb

    Measured: 2 weeks

  13. weight in lbs

    Weight will be measure to the nearest 0.1 lb

    Measured: 6 weeks

  14. height in centimeters

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

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start21 Jan 2020
  3. Primary completion13 Oct 2022
  4. Study completion13 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05589467
Sponsor's protocol ID
IRB2019-880
Status last verified
Jul 2024
First submitted
16 Sep 2022
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • International Diabetes Federation. IDF Diabetes Atlas, 9th Edn. Brussels, Belgium: International Diabetes Federation, 2019. http://www.diabetesatlas.org

  • Gurushankar Govindarajan, James R Sowers, Craig S Stump (2016) Volume 2, Issue 1 Hypertension and Diabetes Mellitus https://doi.org/10.15420/ecr.2006.1.21

  • Aljuraiban GS, Pertiwi K, Stamler J, Chan Q, Geleijnse JM, Van Horn L, Daviglus ML, Elliott P, Oude Griep LM; INTERMAP Research Group. Potato consumption, by preparation method and meal quality, with blood pressure and body mass index: The INTERMAP study. Clin Nutr. 2020 Oct;39(10):3042-3048. doi: 10.1016/j.clnu.2020.01.007. Epub 2020 Jan 22.

    PubMed 32037285

  • Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.

    PubMed 9099655

  • Azadbakht L, Fard NR, Karimi M, Baghaei MH, Surkan PJ, Rahimi M, Esmaillzadeh A, Willett WC. Effects of the Dietary Approaches to Stop Hypertension (DASH) eating plan on cardiovascular risks among type 2 diabetic patients: a randomized crossover clinical trial. Diabetes Care. 2011 Jan;34(1):55-7. doi: 10.2337/dc10-0676. Epub 2010 Sep 15.

    PubMed 20843978

  • Azadbakht L, Mirmiran P, Esmaillzadeh A, Azizi T, Azizi F. Beneficial effects of a Dietary Approaches to Stop Hypertension eating plan on features of the metabolic syndrome. Diabetes Care. 2005 Dec;28(12):2823-31. doi: 10.2337/diacare.28.12.2823.

    PubMed 16306540

  • Beals, K. A. (2019). Potatoes, Nutrition and Health. American Journal of Potato Research, 96(2), 102-110. doi:10.1007/s12230-018-09705-4

  • Berraho M, El Achhab Y, Benslimane A, El Rhazi K, Chikri M, Nejjari C. Hypertension and type 2 diabetes: a cross-sectional study in Morocco (EPIDIAM Study). Pan Afr Med J. 2012;11:52. Epub 2012 Mar 20.

    PubMed 22593788

  • Challa, H. J., Ameer, M. A., & Uppaluri, K. R. (2020). DASH Diet (Dietary Approaches to Stop Hypertension). In StatPearls. Treasure Island (FL): StatPearls Publishing Copyright © 2020, StatPearls Publishing LLC. 35 45 44

  • Challa, H. J., Tadi, P., & Uppaluri, K. R. (2019). DASH Diet (Dietary Approaches to Stop Hypertension): StatPearls Publishing, Treasure Island (FL).

  • Chen G, McAlister FA, Walker RL, Hemmelgarn BR, Campbell NR. Cardiovascular outcomes in framingham participants with diabetes: the importance of blood pressure. Hypertension. 2011 May;57(5):891-7. doi: 10.1161/HYPERTENSIONAHA.110.162446. Epub 2011 Mar 14.

    PubMed 21403089

  • Cheung BM, Li C. Diabetes and hypertension: is there a common metabolic pathway? Curr Atheroscler Rep. 2012 Apr;14(2):160-6. doi: 10.1007/s11883-012-0227-2.

    PubMed 22281657

  • Cook NR, Cutler JA, Obarzanek E, Buring JE, Rexrode KM, Kumanyika SK, Appel LJ, Whelton PK. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ. 2007 Apr 28;334(7599):885-8. doi: 10.1136/bmj.39147.604896.55. Epub 2007 Apr 20.

    PubMed 17449506

  • de Paula TP, Steemburgo T, de Almeida JC, Dall'Alba V, Gross JL, de Azevedo MJ. The role of Dietary Approaches to Stop Hypertension (DASH) diet food groups in blood pressure in type 2 diabetes. Br J Nutr. 2012 Jul 14;108(1):155-62. doi: 10.1017/S0007114511005381. Epub 2011 Dec 6.

    PubMed 22142820

  • Drewnowski A. The Nutrient Rich Foods Index helps to identify healthy, affordable foods. Am J Clin Nutr. 2010 Apr;91(4):1095S-1101S. doi: 10.3945/ajcn.2010.28450D. Epub 2010 Feb 24.

    PubMed 20181811

Questions about this trial

What is this clinical trial studying?

A study testing DASH-FP and DASH-NFP in people with Type 2 Diabetes and Blood Pressure, run by Texas Tech University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic and Diastolic blood pressure in mmHg (time frame: at baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05589467, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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