The Effects of Nitrate-Rich Mouthwash on Vascular Tone (NITRATONE)
The Short-Term Effects of Nitrate-Rich Mouthwash on Oral Bacterial Nitrite Production, Blood Pressure, and Nitrate and Nitrite Concentrations in Plasma and Saliva of Healthy Adults
High blood pressure (hypertension) is a major risk factor for cardiovascular disease. One important contributing factor to high blood pressure is reduced availability of nitric oxide (NO). Therefore, NO is an important molecule in maintaining healthy blood vessel function.
Dietary nitrate, found in leafy greens, can serve as an alternative source of nitric oxide in the body. After ingestion, nitrate is converted to nitrite by bacteria residing in the oral cavity. Nitrite can subsequently be converted to NO when swallowed. Therefore, this nitrate-nitrite-nitric oxide pathway is dependent on oral bacteria.
This study aims to assess whether rinsing the mouth with a nitrate-rich mouth rinse influences blood pressure in healthy adults. Also, concentrations of nitrate and nitrite in plasma and saliva will be measured following the nitrate-mouth rinse exposure.
연구 개요
상태
정황
상세 설명
This study investigates the potential acute blood pressure lowering effects of a simple nitrate-rich mouth rinse and drink, while also monitoring their effects on oral nitrite production capacity (NPC), plasma and salivary nitrate and nitrite levels, oral pH levels and the oral microbiology.
The study is a short-term, double-blind, randomized, placebo-controlled, crossover trial.
Participants will receive interventions and donate samples at four separate sessions. At session (i), baseline measurements are taken prior to intervention, and samples are subsequently taken (as described under outcome measures). At session (i) and (ii), the participants will rinse the oral cavity with a nitrate-rich fluid (or placebo). Similarly for sessions (iii) and (iv), the participants will drink the same fluid (or placebo). When donating samples, the participants will be in fasting condition. In total there will be four sessions per participant with wash-out periods in-between.
To elucidate the short-term effects of the above-described interventions, sampling will be performed in the clinic at multiple time points during the first 2 hours after each intervention, as well as at 24 hours. Participants will also monitor their blood pressure at home at four different time points for all four interventions. No sampling or measurements will be performed during night-time.
For both the intervention and the placebo, potassium (K) salts are used (KNO3 and KCl). For chairside measurement of NPC in oral samples, the rapid Griess assay (RGA) will be used. Blood pressure will be measured at the study facilities as clinic blood pressure and orthostatic blood pressure (CBP and OBP, respectively) using a clinically validated blood pressure monitor. The same device will be used by the participants for home blood pressure measurements (HBP). Saliva pH will be measured using pH-sticks or a pH-meter. Plasma and saliva nitrate- and nitrite levels are analyzed using commercial laboratory kits. Salivary secretion rate (SCR) is recorded during saliva donation, and measured as volume per unit time. Microbiological effects will be analyzed with appropriate methods in the laboratory.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Simeon KB Mavropoulos, DDS, MSc
- 전화번호: +46766185930
- 이메일: simeon.mavropoulos@gu.se
연구 연락처 백업
- 이름: Amina Basic, PhD, DDS
- 전화번호: +46766185930
- 이메일: amina.basic@gu.se
연구 장소
-
-
Västra Götaland County
-
Gothenburg, Västra Götaland County, 스웨덴, 41390
- Odontologen, University of Gothenburg
-
연락하다:
- Amina Basic, DDS, PhD
- 전화번호: +46766185930
- 이메일: amina.basic@gu.se
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- ≥18 years of age; and
- clinic blood pressure <140/<90 mmHg.
Exclusion criteria:
- hypertension;
- systemic medication (other than the oral contraceptive pill);
- antibiotic treatment within the last 3 months;
- active smoking status and BMI > 30;
- prior gastric by-pass surgery;
- self-reported use of antiseptic mouthwash or toothpaste;
- self-reported use of tongue scrapes; and
- active periodontal disease or caries that needs treatment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Test mouth rinse
In this arm participants will receive nitrate rich-mouth rinse
|
The oral cavity is rinsed with nitrate from mouth rinse, rather than ingested.
다른 이름들:
|
|
위약 비교기: Placebo mouth rinse
In this arm participants will receive placebo mouth rinse
|
This mouth rinse is devoid of nitrates
This drink is devoid of nitrates
|
|
활성 비교기: Test drink
In this arm participants will receive nitrate-rich drink
|
Nitrate is ingested, rather than rinsed and spit out
다른 이름들:
|
|
위약 비교기: Placebo drink
In this arm participants will receive placebo drink
|
This mouth rinse is devoid of nitrates
This drink is devoid of nitrates
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Blood pressure will be measured before and with regular intervals after nitrate exposure.
The measurements will be registered as systolic and diastolic measurements from clinic blood pressure and home blood pressure.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
Oral nitrite production before and at regular intervals within the 24 hours after nitrate exposure.
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure
|
The nitrite production is measured using the rapid Griess assay (RGA) - a chairside semi-quantitative nitrite concentration estimation tool for use in several different oral samples.
The RGA provides nitrite estimation on a grading scale of 0-5 with nitrite concentrations intervals.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma and salivary nitrate and nitrite levels before and after nitrate exposure.
기간: Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
|
Blood samples are drawn from venous blood before and 1 hour after nitrate exposure, and plasma is separated.
Saliva nitrate/nitrite is extracted from saliva samples donated before and 1 hour after nitrate exposure.
Both are analyzed using commercial laboratory kits.
|
Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
|
|
Salivary pH levels at regular intervals.
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Salivary pH will be measured using a pH-stick at regular intervals before and after nitrate exposure.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
Orthostatic blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Orthostatic blood pressure will be measured at regular intervals before and after nitrate exposure and reported as systolic and diastolic blood pressure values in mmHg.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
Salivary secretion rate before and after nitrate exposure.
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Salivary secretion rate will be registered as volume per unit time when donating saliva before and after nitrate exposure with regular intervals.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
Relative abundance in cultivable oral microbial composition after nitrate exposure
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Microbial samples from multiple oral sites will be collected before and after nitrate exposure.
Oral microbial composition will be analyzed and reported as the relative abundance (%).
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
Absolute abundance in cultivable oral microbial composition after nitrate exposure
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Microbial samples from multiple oral sites will be collected before and after nitrate exposure.
Cultivable oral microbial composition will be analyzed and reported as absolute abundance and expressed as colony-forming units per milliliter (CFU/mL).
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
PCR detection of specific oral bacterial after nitrate exposure
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Microbial samples from multiple oral sites will be collected before and after nitrate exposure.
Quantitative PCR analysis will be performed for selected oral bacterial species and reported as bacterial counts or copy numbers.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
|
Oral microbial metabolite concentrations after nitrate exposure
기간: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
Microbial samples from multiple oral sites will be collected before and after nitrate exposure.
Oral microbial metabolites will be analyzed and reported as metabolite concentration values.
|
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Amina Basic, PhD, DDS, Göteborg University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-02639-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
혈압 조절에 대한 임상 시험
-
Assiut University아직 모집하지 않음간질환이 있는 경우 악성종양 식별에 있어서 Blood Pool SUV Ratio의 타당도 원문보기 KCI 원문보기 인용
-
Hangzhou Agile Groups Network Technology Co., Ltd.완전한