Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

Официальное название

Evaluating the Impact of Various Dietary Nitrate Supplementation Forms on Microbiological Markers of Oral Health and Acceptability Among Adult Participants

Обзор

This study aims to investigate the effects of different dietary nitrate supplements, versus placebo, on microbiological and immunological markers associated with oral health in people aged 18-65 years. The main research questions are: * How do different dietary nitrate supplements (beetroot crystals vs. beetroot juice) affect oral health markers, including salivary pH and oral microbiome composition? * What is the acceptability and ease of integrating one of dietary nitrate supplements, made from beetroot but processed as freeze dried crystals or juice, into the daily diet? To answer these questions, the study will compare results from three groups of participants, who will be randomly assigned to one of the following study arms: Group 1: The control group will consume a placebo beetroot supplement completely free of nitrate in juice form. Group 2: The beetroot juice group will consume a beetroot supplement standardised to contain \~ 400 mg of nitrate in juice form. Group 3: The beetroot crystals group will consume a beetroot supplement standardised to contain \~400 mg of nitrate in freeze dried crystal form. The study will follow a randomised, single-blind, placebo-controlled, parallel design, and the intervention will last for four weeks. Data will be collected by providing pre- and post-intervention saliva samples tongue swabs, and various questionnaires will be completed at baseline and at the end of the study. In addition, at the end of the second week of the intervention period, participants will be asked to collect a saliva sample over three consecutive days at home.

Вмешательства

• Пищевая добавка Control (Placebo comparator)
  The control group will consume a placebo supplement, entirely free of nitrate, in the form of juice (70 ml) for four weeks while maintaining their habitual diet.
• Пищевая добавка Juice (Active comparator)
  The juice group will consume a beetroot supplement enriched with \~400 mg of nitrate in juice form (70 ml) for four weeks while maintaining their habitual diet.
• Пищевая добавка Crystals (Experimental)
  The crystals group will consume a beetroot supplement enriched with \~400 mg of nitrate in crystals form (20g) for four weeks while maintaining their habitual diet.

Первичные конечные точки

• Saliva pH [Срок оценки: 4 weeks]
• Oral microbiome [Срок оценки: 4 weeks]

Вторичные конечные точки (8)

• Salivary nitrate/ nitrite concentrations [Срок оценки: 4 weeks]
• Saliva flow rate [Срок оценки: 4 weeks]
• Salivary biomarkers [Срок оценки: 4 weeks]
• Dry mouth severity (Xerostomia) [Срок оценки: 4 weeks]
• Oral hygiene behaviours [Срок оценки: 4 weeks]
• Dietary nitrate intake assessment [Срок оценки: 4 weeks]
• Intervention acceptability [Срок оценки: 4 weeks]
• Participant Compliance [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Healthy volunteers
• Aged 18 - 65 years.

Критерии исключения

• Aged less than 18 or more than 65 years old.
• Current smoking
• Alcohol consumption of greater than14 units per week.
• Diagnosis of a chronic disease (e.g., cardiovascular disease, diabetes, cancer, or gastrointestinal disorders), including oral diseases.
• Use of antibiotics within the past three months or medications/nutritional supplements that may affect the oral cavity (e.g., prebiotics, probiotics, or hormone replacement therapy).
• Regular use of antibacterial mouthwash or xylitol-containing products (e.g., gum or toothpaste) or the use of proton pump inhibitors.
• Presence of braces/invisalign or dentures.
• Known allergy to any food, including beets
• Adherence to dietary restrictions (e.g., weight loss diet)
• Eating disorders that may limit participation in the study.
• Currently pregnant, breastfeeding or trying to become pregnant.
• Participation in other studies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Великобритания · 1 центр

• Newcastle University, Newcastle upon Tyne, Tyne and Wear NE2 4HH — Newcastle

Идентификаторы

NCT: NCT06956612 · 2966/53998

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗