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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Simeon KB Mavropoulos, DDS, MSc
- 電話番号：+46766185930
- メール：simeon.mavropoulos@gu.se
研究連絡先のバックアップ
- 名前：Amina Basic, PhD, DDS
- 電話番号：+46766185930
- メール：amina.basic@gu.se
研究場所
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Västra Götaland County
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Gothenburg、Västra Götaland County、スウェーデン、41390
- Odontologen, University of Gothenburg
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コンタクト：
- Amina Basic, DDS, PhD
- 電話番号：+46766185930
- メール：amina.basic@gu.se
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Test mouth rinse
In this arm participants will receive nitrate rich-mouth rinse
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The oral cavity is rinsed with nitrate from mouth rinse, rather than ingested.
他の名前：
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プラセボコンパレーター：Placebo mouth rinse
In this arm participants will receive placebo mouth rinse
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This mouth rinse is devoid of nitrates
This drink is devoid of nitrates
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アクティブコンパレータ：Test drink
In this arm participants will receive nitrate-rich drink
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Nitrate is ingested, rather than rinsed and spit out
他の名前：
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プラセボコンパレーター：Placebo drink
In this arm participants will receive placebo drink
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This mouth rinse is devoid of nitrates
This drink is devoid of nitrates
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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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.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Oral nitrite production before and at regular intervals within the 24 hours after nitrate exposure.
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure
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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.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Plasma and salivary nitrate and nitrite levels before and after nitrate exposure.
時間枠：Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
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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.
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Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
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Salivary pH levels at regular intervals.
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Salivary pH will be measured using a pH-stick at regular intervals before and after nitrate exposure.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Orthostatic blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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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.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Salivary secretion rate before and after nitrate exposure.
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Salivary secretion rate will be registered as volume per unit time when donating saliva before and after nitrate exposure with regular intervals.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Relative abundance in cultivable oral microbial composition after nitrate exposure
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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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 (%).
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Absolute abundance in cultivable oral microbial composition after nitrate exposure
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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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).
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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PCR detection of specific oral bacterial after nitrate exposure
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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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.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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Oral microbial metabolite concentrations after nitrate exposure
時間枠：Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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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.
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Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Amina Basic, PhD, DDS、Göteborg University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025-02639-01
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