NCT06597708已完成早期 1 期
Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers
Al-Mustansiriyah University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- effect of keto diet on oral health
研究概览
简要总结
This study aims to investigate the impact of short term, two distinct dietary interventions, namely the Keto diet and Intermittent Fasting on oral health by measuring the severity of:
- Periodontal diseases (Gingivitis).
- Oral health status (Plaque index). As well as measuring the impact of these different dietary pattern on the levels of C- Reactive Protein, IL-6, TNF-a in mean of inflammatory biomarkers as well as LL- 37 peptide as well as measuring salivary flow and ph.
Objectives of the study
- Evaluate the impact of Keto diet and Intermittent Fasting on oral health among the Iraqi population.
- Assess changes in inflammatory biomarkers within the study groups before and after the intervention period.
- Compare the effects of Keto diet and Intermittent Fasting on oral health and inflammatory biomarkers between the two intervention groups.
- Examine the variations in oral health and inflammatory biomarkers within each group by comparing the baseline (Iraqi diet) and post-intervention stages.
- Investigate the influence of Keto diet and Intermittent Fasting on the levels of LL37, an antimicrobial peptide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults in good general health with a BMI in the range of 19-30 kg/m2 (overweight and obese cl I).
- •Age 20-35 years.
排除标准
- •low-carbohydrate nutrition already prior to the study.
- •Impaired liver and renal function, kidney stones.
- •Pregnancy or lactation period
- •Diabetes mellitus and any fatty acid-metabolism disorders.
- •Presence of systemic disease (diabetes, hypertension, cardiovascular disease) that may affect oral health.
- •Medications that may affect periodontal health conditions.
- •Use of anti-inflammatory and antibiotic drugs during the last month before the examination.
- •Use of dietary supplements.
- •Wearing orthodontics or prosthodontics appliances.
结局指标
主要结局
effect of keto diet on oral health
时间窗: 30 days
effect of keto diet on oral health by measuring the plaque index and bleeding on probing index
effect of intermittent fasting on oral health
时间窗: 30 days
effect of intermittent fasting on oral health by measuring the plaque index and bleeding on probing index
次要结局
- The effect of intermittent fasting on salivary inflammatory biomarkers(30 days)
- The effect of keto diet on salivary inflammatory biomarkers(30 days)
- comparing the effect of KD and IF on inflammatory biomarkers(30 days)
- comparing the effect of KD and IF on oral health(30 days)
- The effect of intermittent fasting on bodyweight(30 days)
- The effect of keto diet on bodyweight loss(30 days)
- The effect of keto diet on salivary PH(30 days)
- The effect of intermittent fasting on salivary PH(30 days)
研究者
Sarah Thamer Kadhum
Dentist
Al-Mustansiriyah University
研究点 (2)
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