Clinical trial NCT06597708: Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers
Official title: Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gingivitis
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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

1. Evaluate the impact of Keto diet and Intermittent Fasting on oral health among the Iraqi population.
2. Assess changes in inflammatory biomarkers within the study groups before and after the intervention period.
3. Compare the effects of Keto diet and Intermittent Fasting on oral health and inflammatory biomarkers between the two intervention groups.
4. Examine the variations in oral health and inflammatory biomarkers within each group by comparing the baseline (Iraqi diet) and post-intervention stages.
5. Investigate the influence of Keto diet and Intermittent Fasting on the levels of LL37, an antimicrobial peptide.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Smoking.
* Use of dietary supplements.
* Wearing orthodontics or prosthodontics appliances.

Primary outcomes:
measure: effect of keto diet on oral health
timeFrame: 30 days
measure: effect of intermittent fasting on oral health
timeFrame: 30 days
Secondary outcomes:
measure: The effect of keto diet on salivary inflammatory biomarkers
timeFrame: 30 days
measure: The effect of intermittent fasting on salivary inflammatory biomarkers
timeFrame: 30 days
measure: comparing the effect of KD and IF on inflammatory biomarkers
timeFrame: 30 days
measure: comparing the effect of KD and IF on oral health
timeFrame: 30 days
measure: The effect of intermittent fasting on bodyweight
timeFrame: 30 days
measure: The effect of keto diet on bodyweight loss
timeFrame: 30 days
measure: The effect of keto diet on salivary PH
timeFrame: 30 days
measure: The effect of intermittent fasting on salivary PH
timeFrame: 30 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Mustansiriyah
state: Street 6
Study officials:
References: