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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05587855
Other study ID # IRB2021-446
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 30, 2021
Est. completion date August 30, 2023

Study information

Verified date May 2023
Source Texas Tech University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date August 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Clinical diagnosis hypertension - Age above 18 Exclusion Criteria: - Use of tobacco - Self-reported history of chronic diseases other than hypertension - Allergy to any food - Pregnant or lactating - Alcohol or drug dependence

Study Design


Related Conditions & MeSH terms


Intervention

Other:
E-group
Participants with Hypertension will be assigned to eCulinary medicine

Locations

Country Name City State
United States Texas Tech University Lubbock Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas Tech University McCormick and Company, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (17)

(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).

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Brors G, Pettersen TR, Hansen TB, Fridlund B, Holvold LB, Lund H, Norekval TM. Modes of e-Health delivery in secondary prevention programmes for patients with coronary artery disease: a systematic review. BMC Health Serv Res. 2019 Jun 10;19(1):364. doi: 10.1186/s12913-019-4106-1. — View Citation

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.

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.

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. — View Citation

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. — View Citation

Kalantar-Zadeh K, Mattix-Kramer HJ, Moore LW. Culinary Medicine as a Core Component of the Medical Nutrition Therapy for Kidney Health and Disease. J Ren Nutr. 2021 Jan;31(1):1-4. doi: 10.1053/j.jrn.2020.11.002. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Erratum In: Hypertension. 2018 Jun;71(6):e136-e139. Hypertension. 2018 Sep;72(3):e33. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at baseline
Primary 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. 6 weeks
Primary 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. 1 month post intervention
Primary 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. at baseline
Primary 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. 2 weeks
Primary 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. 4 weeks
Primary 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. 6 weeks
Primary 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. 1 month post intervention
Primary 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. 2 weeks
Primary 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. 4 weeks
Primary 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. 6 weeks
Primary 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. 1 month post intervention
Secondary 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. at baseline
Secondary 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. 2 weeks
Secondary 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. 4 weeks
Secondary 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. 6 weeks
Secondary 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. 1 month post intervention
Secondary 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. at baseline
Secondary 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. 2 weeks
Secondary 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. 4 weeks
Secondary 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. 6 weeks
Secondary 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. 1 month post intervention
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