Salty TasteNCT01982669
Spicy Diet on Salty Taste and Salt Intake
An observational study of Salty Taste and Spicy Diet, run by Zhiming Zhu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Salty Taste, Spicy Diet
- How many people
- 606 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents from four cities(Shenyang, Jinan, Chengdu and Chongqing) in China
Who may be able to join
- Age ≥ 18 years and ≤ 55 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with all study procedures.
Who cannot join
- 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
Show all 9Show fewer
- Severe neural or psychiatric diseases that would preclude fully understand and corporation in the study.
- Pregnancy or lactation
- Unwilling to sign the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Daping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Effects of Spicy Diet on Salty Taste and Salt Intake
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.
Read the 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.
- Conditions
- Salty Taste, Spicy Diet
- Being tested
- No Intervention
- Keywords
- Salty taste, Urinary sodium excretion, Spicy hedonic, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Different degree of spicy food intake | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
Effects of spicy diet on salt intake
Daily spicy food intake was evaluated by diet questionnaire on the first day when the participant was investigated and then 24-hour urine was collected during the following day and salt intake was assessed by 24-hour urinary sodium excretion.
Measured: Day 1
Effects of spicy diet on obesity parameters.
Daily spicy food intake was evaluated by diet questionnaire and body mass index and waist circumference were measured on the first day when the participant was investigated.
Measured: Day 1
Effects of spicy diet on blood pressure
Daily spicy food intake was evaluated by diet questionnaire and systolic and diastolic blood pressure were measured on the first day when the participant was investigated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Salty TasteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhiming Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982669
- Sponsor's protocol ID
- SATIETY-1
- Other IDs
- 2012CB517805
- Status last verified
- Jan 2016
- First submitted
- 27 Oct 2013
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20674858Zhang 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.
PubMed 17347480Hao 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.
PubMed 21246380
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spicy Diet on Salty Taste and Salt Intake
- ClinicalTrials.gov ID
- NCT01982669
- Acronym / sponsor ID
- SATIETY-1
- Conditions
- Salty Taste, Spicy Diet
- Keywords
- Salty taste, Urinary sodium excretion, Spicy hedonic, Blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Zhiming ZhuUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Different degree of spicy food intake | – | Other: No Intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents from four cities(Shenyang, Jinan, Chengdu and Chongqing) in China
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 55 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with all study procedures.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention | Other | Different degree of spicy food intake |
Primary outcome
Effects of spicy diet on salt taste
Time frame: Day 1
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.
3 secondary outcomes
Effects of spicy diet on salt intake
Time frame: Day 1
Effects of spicy diet on obesity parameters.
Time frame: Day 1
Effects of spicy diet on blood pressure
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Results publication: PubMed 20674858Yang 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.
- Results publication: PubMed 17347480Zhang 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.
- Results publication: PubMed 21246380Hao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salty Taste and Spicy Diet, run by Zhiming Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of spicy diet on salt taste (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982669, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.