Capsaicin on Salty Gustatory Cortices

Volunteers Clinical Trial

Official title:

Effects of Capsaicin on Salty Gustatory Cortices in Human

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974037
• Other study ID #: SATIETY-2
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2013
• Last updated: January 7, 2016
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Volunteers

Intervention

Dietary Supplement:
• Capsaicin
Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups
• NaCl
NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups

Locations

Country	Name	City	State
China	Daping Hospital, The Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhiming Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroimaging changes of salty gustatory cortices	Buccal administration of test solution for five mins, and PET/CT scan after 40 mins	45min	No