Capsaicin on Salty Gustatory Cortices

NCT01974037 | Completed Phase 4 DMC

• 1 other identifier: SATIETY-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Volunteers

Outcome Measures

Primary Outcomes (1)

• Neuroimaging changes of salty gustatory cortices

  Buccal administration of test solution for five mins, and PET/CT scan after 40 mins

  45min

Study Arms (8)

Capsaicin_effect subgroup 1

ACTIVE COMPARATOR

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

Dietary Supplement: Capsaicin

Capsaicin_effect subgroup 2

EXPERIMENTAL

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

Dietary Supplement: Capsaicin

Capsaicin_effect subgroup 3

EXPERIMENTAL

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

Dietary Supplement: Capsaicin

Capsaicin_effect subgroup 4

NO INTERVENTION

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

Salt_effect subgroup 1

NO INTERVENTION

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

Salt_effect subgroup 2

EXPERIMENTAL

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

Dietary Supplement: NaCl

Salt_effect subgroup 3

EXPERIMENTAL

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

Dietary Supplement: NaCl

Salt_effect subgroup 4

EXPERIMENTAL

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

Dietary Supplement: NaCl

Interventions

Capsaicin DIETARY_SUPPLEMENT

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

Capsaicin_effect subgroup 1; Capsaicin_effect subgroup 2; Capsaicin_effect subgroup 3

NaCl DIETARY_SUPPLEMENT

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

Salt_effect subgroup 2; Salt_effect subgroup 3; Salt_effect subgroup 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 65 years.
• Willing and able to provide written informed consent.
• Willing and able to comply with all study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhiming Zhu: lead

Study Sites (1)

Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Dept. of Hypertension & Endocrinology

Study Record Dates

• First Submitted: October 27, 2013
• First Posted: November 1, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

CN (1)