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HypertensionNCT05587855

eCulinary Medicine Emphasizing Herbs/Spices to Increase Vegetable Intake

A study testing E-group in people with Hypertension and Diet, Healthy, 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

e-Culinary medicine emphasizes on herbs and spices, will increase consumption of vegetables and reduce sodium in the diets of people with hypertension and lead to a more favorable health profile. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension, Diet, Healthy, Culinary Medicine
What is being tested?
E-group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
30 Jul 2021to 30 Apr 2023
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis hypertension
  • Age above 18

Who cannot join

  • Use of tobacco
  • Self-reported history of chronic diseases other than hypertension
  • Allergy to any food
  • Pregnant or lactating
  • Alcohol or drug dependence

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: Effects of eCulinary Medicine Emphasizing Herbs and Spices to Increase Vegetable Consumption Among Adults With Hypertension

e-Culinary medicine emphasizes on herbs and spices, will increase consumption of vegetables and reduce sodium in the diets of people with hypertension and lead to a more favorable health profile.

Read the detailed description

This will be a randomized controlled intervention in collaboration with physician care clinics. Participants with hypertension will be assigned to an eCulinary medicine group (E-group) or control that will receive recipes without the eCulinary intervention (C-group). The intervention group will receive weekly cooking demonstration videos, a one-time nutrition education session based on the content of the Nutrition Care Manual from the Academy of Nutrition and Dietetics, a bi-weekly phone visit, and will be given a digital blood pressure monitor and a digital weight scale. The cooking demonstrations will focus on utilizing herbs and spices in the preparation of various vegetables using different cooking methods aimed to reduce sodium and increase vegetable consumption. The control group will receive only recipes from the eCulinary intervention as well digital blood pressure monitor and a digital weight scale.

Being tested
E-group
Medical subject headings
Hypertension

What participants receive

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

  • E-groupOther

    Participants with Hypertension will be assigned to eCulinary medicine

Study groups in NCT05587855
Study groupRoleWhat they receive
eCulinary Medicine Group (E-group)ExperimentalThe intervention group will receive weekly cooking demonstrations and education videos via electronic links to use herbs and spices to increase vegetables and reduce sodium in the diet over six weeks
Receives: Other: E-group
Control Group (C-group)No interventionThe control group participants will receive usual care from their physician's clinic and the recipes but without the eCulinary intervention over 6 weeks.

What is being measured

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

  1. Dietary Intake

    Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.

    Measured: at baseline

  2. Dietary Intake

    Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.

    Measured: 6 weeks

  3. Dietary Intake

    Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.

    Measured: 1 month post intervention

  4. Diet Quality

    Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

    Measured: at baseline

  5. Diet Quality

    Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

    Measured: 2 weeks

  6. Diet Quality

    Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

    Measured: 4 weeks

  7. Diet Quality

    Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

    Measured: 6 weeks

  8. Diet Quality

    Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

    Measured: 1 month post intervention

  9. Cooking effectiveness evaluation

    A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.

    Measured: 2 weeks

  10. Cooking effectiveness evaluation

    A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.

    Measured: 4 weeks

  11. Cooking effectiveness evaluation

    A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.

    Measured: 6 weeks

  12. Cooking effectiveness evaluation

    A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.

    Measured: 1 month post intervention

Secondary outcomes (10)
  1. Systolic or Diastolic Blood Pressure

    Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: at baseline

  2. Systolic or Diastolic Blood Pressure

    Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 2 weeks

  3. Systolic or Diastolic Blood Pressure

    Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 4 weeks

  4. Systolic or Diastolic Blood Pressure

    Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 6 weeks

  5. Systolic or Diastolic Blood Pressure

    Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 1 month post intervention

  6. Body Weight

    Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: at baseline

  7. Body Weight

    Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 2 weeks

  8. Body Weight

    Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 4 weeks

  9. Body Weight

    Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 6 weeks

  10. Body Weight

    Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

    Measured: 1 month post intervention

Timeline

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

  1. First posted20 Oct 2022
  2. Study start30 Jul 2021
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a 6-week randomized controlled intervention. Participants with hypertension will be assigned to an eCulinary medicine group (E-group) or control that will receive recipes without the eCulinary intervention (C-group).
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587855
Sponsor's protocol ID
IRB2021-446
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

  • (CDC) CfDCaP. Hypertension Cascade: Hypertension Prevalence, Treatment and Control Estimates Among US Adults Aged 18 Years and Older Applying the Criteria From the American College of Cardiology and American Heart Association's 2017 Hypertension Guideline-NHANES 2013-2016 2019 [cited 2021]. Available from: Million Hearts® (hhs.gov).

  • Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.

    PubMed 29133354
  • Aburto NJ, Ziolkovska A, Hooper L, Elliott P, Cappuccio FP, Meerpohl JJ. Effect of lower sodium intake on health: systematic review and meta-analyses. BMJ. 2013 Apr 3;346:f1326. doi: 10.1136/bmj.f1326.

    PubMed 23558163
  • Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, Goldman L. Projected effect of dietary salt reductions on future cardiovascular disease. N Engl J Med. 2010 Feb 18;362(7):590-9. doi: 10.1056/NEJMoa0907355. Epub 2010 Jan 20.

    PubMed 20089957
  • Palar K, Sturm R. Potential societal savings from reduced sodium consumption in the U.S. adult population. Am J Health Promot. 2009 Sep-Oct;24(1):49-57. doi: 10.4278/ajhp.080826-QUAN-164.

    PubMed 19750962
  • Fritts JR, Fort C, Quinn Corr A, Liang Q, Alla L, Cravener T, et al. Herbs and spices increase liking and preference for vegetables among rural high school students. Food Quality and Preference. 2018;68:125-34. doi: https://doi.org/10.1016/j.foodqual.2018.02.013.

  • Anderson CA, Cobb LK, Miller ER 3rd, Woodward M, Hottenstein A, Chang AR, Mongraw-Chaffin M, White K, Charleston J, Tanaka T, Thomas L, Appel LJ. Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial. Am J Clin Nutr. 2015 Sep;102(3):671-9. doi: 10.3945/ajcn.114.100750. Epub 2015 Aug 12.

    PubMed 26269371
  • Wang C, Lee Y, Lee SY. Consumer acceptance of model soup system with varying levels of herbs and salt. J Food Sci. 2014 Oct;79(10):S2098-106. doi: 10.1111/1750-3841.12637. Epub 2014 Sep 12.

    PubMed 25220863
  • Ghawi SK, Rowland I, Methven L. Enhancing consumer liking of low salt tomato soup over repeated exposure by herb and spice seasonings. Appetite. 2014 Oct;81:20-9. doi: 10.1016/j.appet.2014.05.029. Epub 2014 May 28.

    PubMed 24879887
  • Aburto NJ, Hanson S, Gutierrez H, Hooper L, Elliott P, Cappuccio FP. Effect of increased potassium intake on cardiovascular risk factors and disease: systematic review and meta-analyses. BMJ. 2013 Apr 3;346:f1378. doi: 10.1136/bmj.f1378.

    PubMed 23558164
  • Services USDoAaUSDoHaH. Dietary Guidelines for Americans, 2020-2025 2020 [cited 2021].

  • Kimmons J, Gillespie C, Seymour J, Serdula M, Blanck HM. Fruit and vegetable intake among adolescents and adults in the United States: percentage meeting individualized recommendations. Medscape J Med. 2009;11(1):26. Epub 2009 Jan 26.

    PubMed 19295947
  • Lucan SC, Barg FK, Long JA. Promoters and barriers to fruit, vegetable, and fast-food consumption among urban, low-income African Americans--a qualitative approach. Am J Public Health. 2010 Apr;100(4):631-5. doi: 10.2105/AJPH.2009.172692. Epub 2010 Feb 18.

    PubMed 20167885
  • Irl B H, Evert A, Fleming A, Gaudiani LM, Guggenmos KJ, Kaufer DI, McGill JB, Verderese CA, Martinez J. Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention. Clin Ther. 2019 Oct;41(10):2184-2198. doi: 10.1016/j.clinthera.2019.08.009. Epub 2019 Sep 20.

    PubMed 31543284
  • Casagrande SS, Gary-Webb TL. Chapter 8 - Trends in US Adult Fruit and Vegetable Consumption. In: Watson RR, Preedy VR, editors. Bioactive Foods in Promoting Health. San Diego: Academic Press; 2010. p. 111-30.

Questions about this trial

What is this clinical trial studying?

A study testing E-group in people with Hypertension and Diet, Healthy, 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 2 inclusion and 5 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?

Dietary Intake (time frame: at baseline). The study lists 12 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 NCT05587855, which also lists 17 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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