Capsaicin on Salty Gustatory Cortices

Sponsor

Zhiming Zhu (Other)

Overall Status

Completed

CT.gov ID

NCT01974037

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 1, 2013

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Neuroimaging changes of salty gustatory cortices [45min]
Buccal administration of test solution for five mins, and PET/CT scan after 40 mins

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daping Hospital, The Third Military Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

Zhiming Zhu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Nov 1, 2013

Last Update Posted:

Jan 11, 2016

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Capsaicin

Study Results

No Results Posted as of Jan 11, 2016