Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Capsaicin on Salty Gustatory Cortices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01974037
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Volunteers Dietary Supplement: Capsaicin Dietary Supplement: NaCl Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Capsaicin on Salty Gustatory Cortices in Human
Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Active Comparator: Capsaicin_effect subgroup 1
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water with capsaicin.
Dietary Supplement: Capsaicin
Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups

Experimental: Capsaicin_effect subgroup 2
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl with capsaicin.
Dietary Supplement: Capsaicin
Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups

Experimental: Capsaicin_effect subgroup 3
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl with capsaicin.
Dietary Supplement: Capsaicin
Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups

No Intervention: Capsaicin_effect subgroup 4
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl.
No Intervention: Salt_effect subgroup 1
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water.
Experimental: Salt_effect subgroup 2
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl.
Dietary Supplement: NaCl
NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups

Experimental: Salt_effect subgroup 3
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl.
Dietary Supplement: NaCl
NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups

Experimental: Salt_effect subgroup 4
The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl.
Dietary Supplement: NaCl
NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups




Primary Outcome Measures :
  1. Neuroimaging changes of salty gustatory cortices [ Time Frame: 45min ]
    Buccal administration of test solution for five mins, and PET/CT scan after 40 mins



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 65 years.
  • Willing and able to provide written informed consent.
  • Willing and able to comply with all study procedures.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974037


Locations
Layout table for location information
China, Chongqing
Daping Hospital, The Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Zhiming Zhu
Layout table for additonal information
Responsible Party: Zhiming Zhu, Director of the Dept. of Hypertension & Endocrinology, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01974037    
Other Study ID Numbers: SATIETY-2
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs