Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers

Early Phase 1

Completed

• Conditions: Gingivitis

• Registration Number: NCT06597708
• Lead Sponsor: Al-Mustansiriyah University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
effect of keto diet on oral health	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	30 days	effect of intermittent fasting on oral health by measuring the plaque index and bleeding on probing index

Secondary Outcome Measures

Name	Time	Method
The effect of keto diet on bodyweight loss	30 days	The effect of keto diet on bodyweight loss for overweight and obese cl I participants
The effect of keto diet on salivary PH	30 days	The effect of keto diet on salivary PH ( an increase or decrease)
The effect of intermittent fasting on salivary PH	30 days	The effect of intermittent fasting on salivary PH ( an increase or decrease)
The effect of keto diet on salivary inflammatory biomarkers	30 days	effect of keto diet on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)
The effect of intermittent fasting on salivary inflammatory biomarkers	30 days	effect of intermittent fasting on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)
comparing the effect of KD and IF on inflammatory biomarkers	30 days	comparing the effect of keto diet and intermittent fasting on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)
comparing the effect of KD and IF on oral health	30 days	comparing the effect of KD and IF on oral health by measuring the plaque index and bleeding on probing index
The effect of intermittent fasting on bodyweight	30 days	The effect of intermittent fasting on bodyweight loss for overweight and obese cl I participants

Trial Locations

Locations (1)

University of Mustansiriyah; 🇮🇶 Baghdad, Street 6, Iraq