Education to Decrease in Sodium Intake Evaluated With 24 Hour Urinary Sodium Excretion (RCT)

NCT04894344 | Completed DMC

• 1 other identifier: ArchiveBioethicsCommittee/245
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

WHO identifies as an important risk factor and potentially modifiable to high sodium intake (\>2g/day 5g salt/day). Also, an insufficient consumption of potassium ( 3.5 g/day).Therefore, the results of this research could be the regional basis that is required to generate evidence, that designs strategies and recommendations for the prevention or decrease in the progression of high blood pressure. The reduction in the consumption of salt in the diet could comply with the recommendations established by international agencies. In addition, to favor the beginning of lifestyle changes, as well as other modifications that will have a positive impact on health.In population highly vulnerable to the campaigns of large industries that favor the consumption of processed food. However, it is unknown what is the effect of reducing foods high in sodium in populations in different regions of Mexico, estimated by 24 hour urine sodium excretion. Therefore, the present study aims to answer the following questions: What impact does an intervention aimed at the decrease in sodium intake, in young university students on blood pressure and the quantification of the excretion of sodium and urinary potassium of 24h? What is the association between body mass index, blood pressure and sodium reduction in the intervention vs control group? To assess the impact of an intervention aimed at reducing sodium intake through education as general recommendations for limiting specific foods high in sodium, in university students on blood pressure and quantification of urinary sodium and potassium excretion of 24h. Specific objectives Assess sodium intake between the intervention group and the control group by estimating 24-hour urinary sodium excretion. secundary objectives Evaluate the effect between the intervention group and the control group on blood pressure. To assess the levels of potassium excretion in the intervention and control groups. To evaluate the association between body mass index, blood pressure and sodium reduction in the intervention and control groups.

Conditions

Hypertension; Overweight or Obesity; Diabetes Mellitus, Type 2

Keywords

Collections, Urine Specimen; Diets, Healthy; Lifestyle; Mentoring; Planning,Health; Sodium,Dietary; Females; Males

Outcome Measures

Primary Outcomes (2)

• 24-hour urine sodium excretion

  mmol/l

  up to 4 weeks

• blood pressure

  mmHg

  up to 4 weeks

Secondary Outcomes (2)

• 24-hour urine potassium excretion

  up to 4 weeks

• Physical activity

  up to 4 weeks

Study Arms (2)

Educational program

EXPERIMENTAL

Participants will be randomly assigned. Intervention Group: 57 participants Each participant will receive the same educational information throughout the study, each week a newsletter will be provided with recommendations and information that teaches them to choose low-sodium foods for 4 weeks. Urine samples of 24 h before and after the Intervention will be analyzed.

Behavioral: Education group

Control group

NO INTERVENTION

Participants will be randomly assigned. Control group:57 participants Follow-up for 4 weeks. Urine samples of 24 h before and after the educational program will be analyzed.

Interventions

Education group BEHAVIORAL

Is taught to choose low-sodium foods

Educational program

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young men and women 18-40 years of age with diastolic blood pressure \<90 and systolic blood pressure \< 130.

You may not qualify if:

• Chronic non-hypertensive diseases
• Physical disability
• Subjects under treatment with diuretics
• Pregnant women, lactating or in their menstrual cycle
• High performance athletes

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Naysin Yaheko Pardo Buitimea

Tijuana, Estado de Baja California, 22457, Mexico

Location

Related Publications (30)

• Bakris G, Ali W, Parati G. ACC/AHA Versus ESC/ESH on Hypertension Guidelines: JACC Guideline Comparison. J Am Coll Cardiol. 2019 Jun 18;73(23):3018-3026. doi: 10.1016/j.jacc.2019.03.507.

  PMID: 31196460 RESULT

• Forrester T, Adeyemo A, Soarres-Wynter S, Sargent L, Bennett F, Wilks R, Luke A, Prewitt E, Kramer H, Cooper RS. A randomized trial on sodium reduction in two developing countries. J Hum Hypertens. 2005 Jan;19(1):55-60. doi: 10.1038/sj.jhh.1001782.

  PMID: 15470483 RESULT

• Stamler J, Chan Q, Daviglus ML, Dyer AR, Van Horn L, Garside DB, Miura K, Wu Y, Ueshima H, Zhao L, Elliott P; INTERMAP Research Group. Relation of Dietary Sodium (Salt) to Blood Pressure and Its Possible Modulation by Other Dietary Factors: The INTERMAP Study. Hypertension. 2018 Apr;71(4):631-637. doi: 10.1161/HYPERTENSIONAHA.117.09928.

  PMID: 29507099 RESULT

• Weinberger MH. Salt sensitivity is associated with an increased mortality in both normal and hypertensive humans. J Clin Hypertens (Greenwich). 2002 Jul-Aug;4(4):274-6. doi: 10.1111/j.1524-6175.2002.00924.x.

  PMID: 12147930 RESULT

• Drenjancevic-Peric I, Frisbee JC, Lombard JH. Skeletal muscle arteriolar reactivity in SS.BN13 consomic rats and Dahl salt-sensitive rats. Hypertension. 2003 May;41(5):1012-5. doi: 10.1161/01.HYP.0000067061.26899.3E. Epub 2003 Apr 7.

  PMID: 12682080 RESULT

• Drenjancevic-Peric I, Jelakovic B, Lombard JH, Kunert MP, Kibel A, Gros M. High-salt diet and hypertension: focus on the renin-angiotensin system. Kidney Blood Press Res. 2011;34(1):1-11. doi: 10.1159/000320387. Epub 2010 Nov 12.

  PMID: 21071956 RESULT

• Larsen SC, Angquist L, Sorensen TI, Heitmann BL. 24h urinary sodium excretion and subsequent change in weight, waist circumference and body composition. PLoS One. 2013 Jul 25;8(7):e69689. doi: 10.1371/journal.pone.0069689. Print 2013.

  PMID: 23936079 RESULT

• Fonseca-Alaniz MH, Brito LC, Borges-Silva CN, Takada J, Andreotti S, Lima FB. High dietary sodium intake increases white adipose tissue mass and plasma leptin in rats. Obesity (Silver Spring). 2007 Sep;15(9):2200-8. doi: 10.1038/oby.2007.261.

  PMID: 17890487 RESULT

• Smith-Spangler CM, Juusola JL, Enns EA, Owens DK, Garber AM. Population strategies to decrease sodium intake and the burden of cardiovascular disease: a cost-effectiveness analysis. Ann Intern Med. 2010 Apr 20;152(8):481-7, W170-3. doi: 10.7326/0003-4819-152-8-201004200-00212. Epub 2010 Mar 1.

  PMID: 20194225 RESULT

• Vedovato M, Lepore G, Coracina A, Dodesini AR, Jori E, Tiengo A, Del Prato S, Trevisan R. Effect of sodium intake on blood pressure and albuminuria in Type 2 diabetic patients: the role of insulin resistance. Diabetologia. 2004 Feb;47(2):300-3. doi: 10.1007/s00125-003-1303-5. Epub 2003 Dec 24.

  PMID: 14704836 RESULT

• Wilck N, Balogh A, Marko L, Bartolomaeus H, Muller DN. The role of sodium in modulating immune cell function. Nat Rev Nephrol. 2019 Sep;15(9):546-558. doi: 10.1038/s41581-019-0167-y. Epub 2019 Jun 25.

  PMID: 31239546 RESULT

• Strazzullo P, Cairella G, Campanozzi A, Carcea M, Galeone D, Galletti F, Giampaoli S, Iacoviello L, Scalfi L; GIRCSI Working Group. Population based strategy for dietary salt intake reduction: Italian initiatives in the European framework. Nutr Metab Cardiovasc Dis. 2012 Mar;22(3):161-6. doi: 10.1016/j.numecd.2011.10.004. Epub 2012 Feb 23.

  PMID: 22364888 RESULT

• Vega-Solano J, Blanco-Metzler A, Benavides-Aguilar KF, Arcand J. An Evaluation of the Sodium Content and Compliance with the National Sodium Reduction Targets among Packaged Foods Sold in Costa Rica in 2015 and 2018. Nutrients. 2019 Sep 15;11(9):2226. doi: 10.3390/nu11092226.

  PMID: 31540146 RESULT

• Manzel A, Muller DN, Hafler DA, Erdman SE, Linker RA, Kleinewietfeld M. Role of "Western diet" in inflammatory autoimmune diseases. Curr Allergy Asthma Rep. 2014 Jan;14(1):404. doi: 10.1007/s11882-013-0404-6.

  PMID: 24338487 RESULT

• Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.

  PMID: 26498129 RESULT

• Meneton P, Jeunemaitre X, de Wardener HE, MacGregor GA. Links between dietary salt intake, renal salt handling, blood pressure, and cardiovascular diseases. Physiol Rev. 2005 Apr;85(2):679-715. doi: 10.1152/physrev.00056.2003.

  PMID: 15788708 RESULT

• 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.

  PMID: 17449506 RESULT

• Cook NR, Obarzanek E, Cutler JA, Buring JE, Rexrode KM, Kumanyika SK, Appel LJ, Whelton PK; Trials of Hypertension Prevention Collaborative Research Group. Joint effects of sodium and potassium intake on subsequent cardiovascular disease: the Trials of Hypertension Prevention follow-up study. Arch Intern Med. 2009 Jan 12;169(1):32-40. doi: 10.1001/archinternmed.2008.523.

  PMID: 19139321 RESULT

• Greaney JL, DuPont JJ, Lennon-Edwards SL, Sanders PW, Edwards DG, Farquhar WB. Dietary sodium loading impairs microvascular function independent of blood pressure in humans: role of oxidative stress. J Physiol. 2012 Nov 1;590(21):5519-28. doi: 10.1113/jphysiol.2012.236992. Epub 2012 Aug 20.

  PMID: 22907057 RESULT

• Rossi M, Carpi A, Galetta F, Franzoni F, Santoro G. The investigation of skin blood flowmotion: a new approach to study the microcirculatory impairment in vascular diseases? Biomed Pharmacother. 2006 Sep;60(8):437-42. doi: 10.1016/j.biopha.2006.07.012. Epub 2006 Aug 14.

  PMID: 16935461 RESULT

• Todd AS, Macginley RJ, Schollum JB, Williams SM, Sutherland WH, Mann JI, Walker RJ. Dietary sodium loading in normotensive healthy volunteers does not increase arterial vascular reactivity or blood pressure. Nephrology (Carlton). 2012 Mar;17(3):249-56. doi: 10.1111/j.1440-1797.2011.01550.x.

  PMID: 22171802 RESULT

• Gates PE, Tanaka H, Hiatt WR, Seals DR. Dietary sodium restriction rapidly improves large elastic artery compliance in older adults with systolic hypertension. Hypertension. 2004 Jul;44(1):35-41. doi: 10.1161/01.HYP.0000132767.74476.64. Epub 2004 Jun 1.

  PMID: 15173128 RESULT

• Mascioli S, Grimm R Jr, Launer C, Svendsen K, Flack J, Gonzalez N, Elmer P, Neaton J. Sodium chloride raises blood pressure in normotensive subjects. The study of sodium and blood pressure. Hypertension. 1991 Jan;17(1 Suppl):I21-6. doi: 10.1161/01.hyp.17.1_suppl.i21.

  PMID: 1987006 RESULT

• Caldeira D, Vaz-Carneiro A, Costa J. [What is the benefit of salt reduction on blood pressure? Assessment of the Cochrane Review: Effect of longer-term modest salt reduction on blood pressure. He FJ, Li J, Macgregor GA. Cochrane Database Syst Rev. 2013 Apr 30;4:CD004937]. Acta Med Port. 2013 Sep-Oct;26(5):490-2. Epub 2013 Oct 31. Portuguese.

  PMID: 24192084 RESULT

• Suckling RJ, He FJ, Markandu ND, MacGregor GA. Modest Salt Reduction Lowers Blood Pressure and Albumin Excretion in Impaired Glucose Tolerance and Type 2 Diabetes Mellitus: A Randomized Double-Blind Trial. Hypertension. 2016 Jun;67(6):1189-95. doi: 10.1161/HYPERTENSIONAHA.115.06637.

  PMID: 27160199 RESULT

• Chen J, Tian Y, Liao Y, Yang S, Li Z, He C, Tu D, Sun X. Salt-restriction-spoon improved the salt intake among residents in China. PLoS One. 2013 Nov 11;8(11):e78963. doi: 10.1371/journal.pone.0078963. eCollection 2013.

  PMID: 24244395 RESULT

• Aparicio A, Rodriguez-Rodriguez E, Cuadrado-Soto E, Navia B, Lopez-Sobaler AM, Ortega RM. Estimation of salt intake assessed by urinary excretion of sodium over 24 h in Spanish subjects aged 7-11 years. Eur J Nutr. 2017 Feb;56(1):171-178. doi: 10.1007/s00394-015-1067-y. Epub 2015 Oct 19.

  PMID: 26482149 RESULT

• Hoffmann IS, Cubeddu LX. Salt and the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2009 Feb;19(2):123-8. doi: 10.1016/j.numecd.2008.02.011. Epub 2008 Jun 16.

  PMID: 18556187 RESULT

• Strazzullo P, D'Elia L, Kandala NB, Cappuccio FP. Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ. 2009 Nov 24;339:b4567. doi: 10.1136/bmj.b4567.

  PMID: 19934192 RESULT

• Kim J, Lim SY, Kim JH. Nutrient intake risk factors of osteoporosis in postmenopausal women. Asia Pac J Clin Nutr. 2008;17(2):270-5.

  PMID: 18586647 RESULT

Related Links

• Pan American Health Organization: PAHO/WHO

MeSH Terms

Conditions

Hypertension; Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arturo Jiménez-Cruz, Researcher

  University Autonomus of Baja California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups will be formed, the intervention group and the control group. Participants shall be randomly assigned to one of the two groups. Each patient group receives a single treatment simultaneously Urine measured 24 hours before and after the procedure as well as other variables of interest. The duration of the intervention will be 4 weeks.

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: May 20, 2021
• Study Start: October 28, 2020
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 1 month after publication
• Access Criteria: by email

Locations

ME (1)