Capsaicin on Salty Gustatory Cortices

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.

Study Overview

• Status: Completed
• Conditions: Volunteers
• Intervention / Treatment: Dietary supplement: Capsaicin; Dietary supplement: NaCl

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Daping Hospital, The Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroimaging changes of salty gustatory cortices	Buccal administration of test solution for five mins, and PET/CT scan after 40 mins	45min

Collaborators and Investigators

• Sponsor: Zhiming Zhu

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 27, 2013
• First Submitted That Met QC Criteria: October 27, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: SATIETY-2