Clinical trial NCT01982669: Spicy Diet on Salty Taste and Salt Intake
Official title: Effects of Spicy Diet on Salty Taste and Salt Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salty Taste
Spicy Diet
Keywords: Salty taste
Urinary sodium excretion
Spicy hedonic
Blood pressure
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents from four cities(Shenyang, Jinan, Chengdu and Chongqing) in China

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.

Detailed description: Hypertension and its related complications are common health problems that can lead to multiple organ damage and death. Excessive salt intake plays very important role in the development of hypertension. Reducing salt intake prevents high blood pressure as well as cardiocerebral vascular diseases.

The experimental design is a multi-center, random-order, double-blind observational study to investigate the salty taste and salt intake in population-level.

A total of 606 individuals from four cities in China are recruited in this study. This study aims to explore the salty taste characterization and salt intake in participants who like or dislike spicy diet through questionnaire, spicy preference, salty perception and super-threshold as well as the 24-hour urinary sodium excretion.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effects of spicy diet on salt taste
timeFrame: Day 1
Secondary outcomes:
measure: Effects of spicy diet on salt intake
timeFrame: Day 1
measure: Effects of spicy diet on obesity parameters.
timeFrame: Day 1
measure: Effects of spicy diet on blood pressure
timeFrame: Day 1
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.