NCT00721721

Brief Summary

High blood pressure is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including changes brought on by sodium and potassium. This study will identify genetic factors that may influence blood pressure changes due to increased salt or potassium intake in people with mildly elevated blood pressure and in their family members.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,906

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 29, 2016

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

July 22, 2008

Last Update Submit

July 28, 2016

Conditions

Blood Pressure

Keywords

Dietary SodiumDietary PotassiumGenesGenomics

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Measured at Day 21

Study Arms (1)

1

EXPERIMENTAL

Participants will follow a low sodium diet for Days 1 through 7, a high sodium diet for Days 7 through 14, and a high sodium diet plus potassium supplement regimen for Days 14 through 21.

Behavioral: Low Sodium DietBehavioral: High Sodium DietDietary Supplement: Potassium Supplementation

Interventions

Low Sodium DietBEHAVIORAL

3 grams of salt or 51.3 mmol of sodium per day

1
High Sodium DietBEHAVIORAL

18 grams of salt or 307.8 mmol of sodium per day

1
Potassium SupplementationDIETARY_SUPPLEMENT

60 mmol potassium supplement

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 60 years old
  • Systolic blood pressure level of 130 to 160 mm Hg and/or diastolic blood pressure level of 85 to 100 mm Hg
  • Both parents (2-generation nuclear family) or at least one parent (at least a 3-generation family) is available and willing to participate in the study
  • At least one sibling meets eligibility criteria for participation
  • Siblings and spouses must be between 18 and 60 years old; children must be more than 16 years old
  • Lives in the same village as the main study participant

You may not qualify if:

  • Current stage 2 hypertension (systolic blood pressure level greater than or equal to 160 mm Hg and/or diastolic blood pressure level greater than or equal to 100 mm Hg)
  • Current or recent (i.e., less than 1 month before the screening visit) use of antihypertensive medications or medications that affect blood pressure
  • Secondary hypertension
  • History of clinical cardiovascular disease, including heart attack, congestive heart failure, stroke, and peripheral arterial disease
  • Chronic kidney failure or urinary albumin concentration of greater than or equal to 20 mg/dL
  • Current diabetes (i.e., fasting serum glucose level greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
  • Peptic ulcer disease requiring treatment in the 2 years before study entry
  • Liver disease requiring treatment in the 2 years before study entry
  • Pregnant
  • Heavy alcohol drinker (i.e., more than 14 drinks per week)
  • Currently adhering to a low sodium diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (11)

  • GenSalt Collaborative Research Group. GenSalt: rationale, design, methods and baseline characteristics of study participants. J Hum Hypertens. 2007 Aug;21(8):639-46. doi: 10.1038/sj.jhh.1002207. Epub 2007 Apr 19.

    PMID: 17443206RESULT

  • Gu D, Rice T, Wang S, Yang W, Gu C, Chen CS, Hixson JE, Jaquish CE, Yao ZJ, Liu DP, Rao DC, He J. Heritability of blood pressure responses to dietary sodium and potassium intake in a Chinese population. Hypertension. 2007 Jul;50(1):116-22. doi: 10.1161/HYPERTENSIONAHA.107.088310. Epub 2007 May 7.

    PMID: 17485599RESULT

  • Xing X, Liu F, Yang X, Huang C, Zhang D, Chen S, Chen J, Li J, Liu Z, Lu F, Gu D, Huang J. Central Blood Pressure Responses to Dietary Sodium and Potassium Interventions. Am J Hypertens. 2018 Apr 13;31(5):582-589. doi: 10.1093/ajh/hpx209.

    PMID: 29385399DERIVED

  • Gu X, Gu D, He J, Rao DC, Hixson JE, Chen J, Li J, Huang J, Wu X, Rice TK, Shimmin LC, Kelly TN. Resequencing Epithelial Sodium Channel Genes Identifies Rare Variants Associated With Blood Pressure Salt-Sensitivity: The GenSalt Study. Am J Hypertens. 2018 Jan 12;31(2):205-211. doi: 10.1093/ajh/hpx169.

    PMID: 29036630DERIVED

  • Kelly TN, Li C, Hixson JE, Gu D, Rao DC, Huang J, Rice TK, Chen J, Cao J, Li J, Anderson CE, He J. Resequencing Study Identifies Rare Renin-Angiotensin-Aldosterone System Variants Associated With Blood Pressure Salt-Sensitivity: The GenSalt Study. Am J Hypertens. 2017 May 1;30(5):495-501. doi: 10.1093/ajh/hpx004.

    PMID: 28199472DERIVED

  • Yang X, Gu D, He J, Hixson JE, Rao DC, Lu F, Mu J, Jaquish CE, Chen J, Huang J, Shimmin LC, Rice TK, Chen J, Wu X, Liu D, Kelly TN. Genome-wide linkage and regional association study of blood pressure response to the cold pressor test in Han Chinese: the genetic epidemiology network of salt sensitivity study. Circ Cardiovasc Genet. 2014 Aug;7(4):521-8. doi: 10.1161/CIRCGENETICS.113.000332. Epub 2014 Jul 15.

    PMID: 25028485DERIVED

  • Zhao Q, Gu D, Chen J, Li J, Cao J, Lu F, Guo D, Wang R, Shen J, Chen J, Chen CS, Mills KT, Schwander K, Rao DC, He J. Blood pressure responses to dietary sodium and potassium interventions and the cold pressor test: the GenSalt replication study in rural North China. Am J Hypertens. 2014 Jan;27(1):72-80. doi: 10.1093/ajh/hpt163. Epub 2013 Sep 4.

    PMID: 24004934DERIVED

  • Kelly TN, Rebholz CM, Gu D, Hixson JE, Rice TK, Cao J, Chen J, Li J, Lu F, Ma J, Mu J, Whelton PK, He J. Analysis of sex hormone genes reveals gender differences in the genetic etiology of blood pressure salt sensitivity: the GenSalt study. Am J Hypertens. 2013 Feb;26(2):191-200. doi: 10.1093/ajh/hps018. Epub 2012 Dec 28.

    PMID: 23382403DERIVED

  • Zhao Q, Gu D, Hixson JE, Liu DP, Rao DC, Jaquish CE, Kelly TN, Lu F, Ma J, Mu J, Shimmin LC, Chen J, Mei H, Hamm LL, He J; Genetic Epidemiology Network of Salt Sensitivity Collaborative Research Group. Common variants in epithelial sodium channel genes contribute to salt sensitivity of blood pressure: The GenSalt study. Circ Cardiovasc Genet. 2011 Aug 1;4(4):375-80. doi: 10.1161/CIRCGENETICS.110.958629. Epub 2011 May 11.

    PMID: 21562341DERIVED

  • Kelly TN, Hixson JE, Rao DC, Mei H, Rice TK, Jaquish CE, Shimmin LC, Schwander K, Chen CS, Liu D, Chen J, Bormans C, Shukla P, Farhana N, Stuart C, Whelton PK, He J, Gu D. Genome-wide linkage and positional candidate gene study of blood pressure response to dietary potassium intervention: the genetic epidemiology network of salt sensitivity study. Circ Cardiovasc Genet. 2010 Dec;3(6):539-47. doi: 10.1161/CIRCGENETICS.110.940635. Epub 2010 Sep 22.

    PMID: 20861505DERIVED

  • Chen J, Gu D, Huang J, Rao DC, Jaquish CE, Hixson JE, Chen CS, Chen J, Lu F, Hu D, Rice T, Kelly TN, Hamm LL, Whelton PK, He J; GenSalt Collaborative Research Group. Metabolic syndrome and salt sensitivity of blood pressure in non-diabetic people in China: a dietary intervention study. Lancet. 2009 Mar 7;373(9666):829-35. doi: 10.1016/S0140-6736(09)60144-6. Epub 2009 Feb 14.

    PMID: 19223069DERIVED

MeSH Terms

Interventions

Diet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Jiang He, MD, PhD

    Tulane University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

October 1, 2003

Primary Completion

July 1, 2005

Study Completion

May 1, 2009

Last Updated

July 29, 2016

Record last verified: 2008-08

Locations

CN(1)