VolunteersPhase 4NCT01974037
Capsaicin on Salty Gustatory Cortices
A Phase 4 study testing Capsaicin and NaCl in people with Volunteers, 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. Preference of high salt diet might involve salty gustatory cortices change. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Volunteers
- What is being tested?
- Capsaicin and NaCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 65 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with all study procedures.
Who cannot join
- High basic metabolic rate, tumor, epilepsia.
- 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.
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- 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.
- History of allergic reaction attributed to 18F-FDG.
- Pregnancy or lactation.
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 Capsaicin on Salty Gustatory Cortices in Human
Excess dietary salt intake is closely associated with the development of hypertension and cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory cortices change. This study focuses on examining the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.
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 an important role in the development of hypertension.
The experimental design is a randomized, double-blind, interventional study to investigate the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.
- Conditions
- Volunteers
- Being tested
- Capsaicin, NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDietary supplement
Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups
NaClDietary supplement
NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin_effect subgroup 1 | Active comparator | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water with capsaicin. Receives: Dietary Supplement: Capsaicin |
| Capsaicin_effect subgroup 2 | Experimental | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl with capsaicin. Receives: Dietary Supplement: Capsaicin |
| Capsaicin_effect subgroup 3 | Experimental | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl with capsaicin. Receives: Dietary Supplement: Capsaicin |
| Capsaicin_effect subgroup 4 | No intervention | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl. |
| Salt_effect subgroup 1 | No intervention | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water. |
| Salt_effect subgroup 2 | Experimental | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl. Receives: Dietary Supplement: NaCl |
| Salt_effect subgroup 3 | Experimental | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl. Receives: Dietary Supplement: NaCl |
| Salt_effect subgroup 4 | Experimental | The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl. Receives: Dietary Supplement: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimaging changes of salty gustatory cortices
Buccal administration of test solution for five mins, and PET/CT scan after 40 mins
Measured: 45min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT01974037
- Sponsor's protocol ID
- SATIETY-2
- Status last verified
- Jan 2016
- First submitted
- 27 Oct 2013
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Capsaicin on Salty Gustatory Cortices in Human
- ClinicalTrials.gov ID
- NCT01974037
- Acronym / sponsor ID
- SATIETY-2
- Conditions
- Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhiming ZhuUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 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. Preference of high salt diet might involve salty gustatory cortices change. This study focuses on examining the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.
Detailed description
Hypertension and its related complications are common health problems that can lead to multiple organ damage and death. Excessive salt intake plays an important role in the development of hypertension.
The experimental design is a randomized, double-blind, interventional study to investigate the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Capsaicin_effect subgroup 1 | Active comparator | Dietary Supplement: CapsaicinThe volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water with capsaicin. |
| Capsaicin_effect subgroup 2 | Experimental | Dietary Supplement: CapsaicinThe volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl with capsaicin. |
| Capsaicin_effect subgroup 3 | Experimental | Dietary Supplement: CapsaicinThe volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl with capsaicin. |
| Capsaicin_effect subgroup 4 | No intervention | –The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl. |
| Salt_effect subgroup 1 | No intervention | –The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water. |
| Salt_effect subgroup 2 | Experimental | Dietary Supplement: NaClThe volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl. |
| Salt_effect subgroup 3 | Experimental | Dietary Supplement: NaClThe volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl. |
| Salt_effect subgroup 4 | Experimental | Dietary Supplement: NaClThe volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 65 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with all study procedures.
Key exclusion criteria (10 listed)
- High basic metabolic rate, tumor, epilepsia.
- 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.
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 |
|---|---|---|
| CapsaicinCapsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups | Dietary supplement | Capsaicin_effect subgroup 1, Capsaicin_effect subgroup 2, Capsaicin_effect subgroup 3 |
| NaClNaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups | Dietary supplement | Salt_effect subgroup 2, Salt_effect subgroup 3, Salt_effect subgroup 4 |
Primary outcome
Neuroimaging changes of salty gustatory cortices
Time frame: 45min
Buccal administration of test solution for five mins, and PET/CT scan after 40 mins
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.
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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?
A Phase 4 study testing Capsaicin and NaCl in people with Volunteers, 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 10 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neuroimaging changes of salty gustatory cortices (time frame: 45min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.