Capsaicin on Salty Gustatory Cortices

Phase 4

Completed

• Conditions: Volunteers
• Interventions: Dietary Supplement: NaCl; Dietary Supplement: Capsaicin

• Registration Number: NCT01974037
• Lead Sponsor: Zhiming Zhu

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-10
• Study First Submitted: 2013-10-27
• Study First Submitted QC: 2013-10-27
• Study First Posted: 2013-11-01
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salt_effect subgroup 2	NaCl	The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl.
Capsaicin_effect subgroup 2	Capsaicin	The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 100 mmol/L NaCl with capsaicin.
Capsaicin_effect subgroup 3	Capsaicin	The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl with capsaicin.
Salt_effect subgroup 3	NaCl	The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 150 mmol/L NaCl.
Capsaicin_effect subgroup 1	Capsaicin	The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of water with capsaicin.
Salt_effect subgroup 4	NaCl	The volunteers allocated to the arm will perform neuroimaging detection with buccal administration of 200 mmol/L NaCl.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Daping Hospital, The Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China