Capsaicin on Salty Gustatory Cortices

NCT ID: NCT01974037

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Capsaicin_effect subgroup 1

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water with capsaicin.

Group Type: ACTIVE_COMPARATOR

Capsaicin

Intervention Type: DIETARY_SUPPLEMENT

Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin\_effect subgroups

Capsaicin_effect subgroup 2

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl with capsaicin.

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DIETARY_SUPPLEMENT

Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin\_effect subgroups

Capsaicin_effect subgroup 3

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl with capsaicin.

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DIETARY_SUPPLEMENT

Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin\_effect subgroups

Capsaicin_effect subgroup 4

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Salt_effect subgroup 1

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Salt_effect subgroup 2

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl.

Group Type: EXPERIMENTAL

NaCl

Intervention Type: DIETARY_SUPPLEMENT

NaCl in various concentrations was desorved in the test solutions in Salt\_effect subgroups

Salt_effect subgroup 3

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl.

Group Type: EXPERIMENTAL

NaCl

Intervention Type: DIETARY_SUPPLEMENT

NaCl in various concentrations was desorved in the test solutions in Salt\_effect subgroups

Salt_effect subgroup 4

The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl.

Group Type: EXPERIMENTAL

NaCl

Intervention Type: DIETARY_SUPPLEMENT

NaCl in various concentrations was desorved in the test solutions in Salt\_effect subgroups

Interventions

Capsaicin

Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin\_effect subgroups

Intervention Type: DIETARY_SUPPLEMENT

NaCl

NaCl in various concentrations was desorved in the test solutions in Salt\_effect subgroups

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhiming Zhu

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

Director of the Dept. of Hypertension & Endocrinology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

SATIETY-2

Identifier Type: -

Identifier Source: org_study_id