NCT01982669

Brief Summary

Excess dietary salt intake is closely associated with the development of hypertension and cardiocerebral vascular diseases. Reduction in high salt intake significantly prevents hypertension and cardiocerebral events. Currently, few promising method is available to reduce salt intake in human. This study focus on examining the salty taste in population-level and exploring whether dietary factors can reduce salt intake through acting on salty taste.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
606

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

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

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

October 27, 2013

Last Update Submit

January 7, 2016

Conditions

Salty TasteSpicy Diet

Keywords

Salty tasteUrinary sodium excretionSpicy hedonicBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Effects of spicy diet on salt taste

    Daily spicy food intake was evaluated by diet questionnaire and salty taste was tested through salt perception and super-threshold examination on the first day when the participant was investigated.

    Day 1

Secondary Outcomes (3)

  • Effects of spicy diet on salt intake

    Day 1

  • Effects of spicy diet on obesity parameters.

    Day 1

  • Effects of spicy diet on blood pressure

    Day 1

Study Arms (1)

Different degree of spicy food intake

Other: No Intervention

Interventions

No InterventionOTHER
Different degree of spicy food intake

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents from four cities(Shenyang, Jinan, Chengdu and Chongqing) in China

You may qualify if:

  • Age ≥ 18 years and ≤ 55 years.
  • Willing and able to provide written informed consent.
  • Willing and able to comply with all study procedures.

You may not qualify if:

  • Hypogeusia or loss due to neural system disease or oral and digestive disease.
  • Capsaicin allergy and poor compliance.
  • Recently oral diuretics and participate in other pharmacological experiment in 3 months.
  • Acute infection, cancer, serious arrhythmias, drug or alcohol abuse.
  • Currently have cold, fever, acidosis, dehydration, diarrhea, vomiting during the study.
  • Unwilling or unable to communication due to the dysnoesia and language disorders
  • Severe neural or psychiatric diseases that would preclude fully understand and corporation in the study.
  • Pregnancy or lactation
  • Unwilling to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (3)

  • Yang D, Luo Z, Ma S, Wong WT, Ma L, Zhong J, He H, Zhao Z, Cao T, Yan Z, Liu D, Arendshorst WJ, Huang Y, Tepel M, Zhu Z. Activation of TRPV1 by dietary capsaicin improves endothelium-dependent vasorelaxation and prevents hypertension. Cell Metab. 2010 Aug 4;12(2):130-41. doi: 10.1016/j.cmet.2010.05.015.

    PMID: 20674858RESULT

  • Zhang LL, Yan Liu D, Ma LQ, Luo ZD, Cao TB, Zhong J, Yan ZC, Wang LJ, Zhao ZG, Zhu SJ, Schrader M, Thilo F, Zhu ZM, Tepel M. Activation of transient receptor potential vanilloid type-1 channel prevents adipogenesis and obesity. Circ Res. 2007 Apr 13;100(7):1063-70. doi: 10.1161/01.RES.0000262653.84850.8b. Epub 2007 Mar 8.

    PMID: 17347480RESULT

  • Hao X, Chen J, Luo Z, He H, Yu H, Ma L, Ma S, Zhu T, Liu D, Zhu Z. TRPV1 activation prevents high-salt diet-induced nocturnal hypertension in mice. Pflugers Arch. 2011 Mar;461(3):345-53. doi: 10.1007/s00424-011-0921-x. Epub 2011 Jan 19.

    PMID: 21246380RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Dept. of Hypertension & Endocrinology

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 13, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

CN(1)