Capsaicin on Salty Gustatory Cortices

Zhiming Zhu

Status and phase: Completed; Phase 4

Conditions: Volunteers

Treatments: Dietary Supplement: NaCl; Dietary Supplement: Capsaicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01974037

SATIETY-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 8 patient groups

Capsaicin_effect subgroup 1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Capsaicin

Capsaicin_effect subgroup 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Capsaicin

Capsaicin_effect subgroup 3

Experimental group

Description:

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

Treatment:

Dietary Supplement: Capsaicin

Capsaicin_effect subgroup 4

No Intervention group

Description:

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

Salt_effect subgroup 1

No Intervention group

Description:

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

Salt_effect subgroup 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: NaCl

Salt_effect subgroup 3

Experimental group

Description:

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

Treatment:

Dietary Supplement: NaCl

Salt_effect subgroup 4

Experimental group

Description:

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

Treatment:

Dietary Supplement: NaCl