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

Early Phase 1

Completed

• Conditions: Gingivitis
• Interventions: Behavioral: keto diet; Behavioral: intermittent fasting with calorie restriction

• 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

Arm && Interventions

Group	Intervention	Description
participants committed to keto diet	keto diet	The experimental intervention consisted of a KD without caloric restriction over a period of 4 weeks. Prior to the study period, the participants were instructed by a dietitian. The participants were provided with online brochure describing the main aspects of a KD and given a list of suitable foods with a very low carbohydrate content. They were advised to eat ad libitum but to limit their carbohydrate intake to a maximum of 20-40 g/day to derive at leasut 75%, 15-20%, and 5-10% of total energy from fats, protein, and carbohydrates, respectively. The participants were allowed to vary the food according to their preferences within the framework of the KD.
participants committed to intermittent fasting with calorie restriction	intermittent fasting with calorie restriction	The 16/8 TRF group was asked to consume their daily calorie intake during an 8-hour window during the daytime and then fast for the remaining 16 hours each day throughout the intervention period. During the 16 hours fasting, they were able to drink water, coffee and tea without sugar. Participants are encouraged to drink 6-8 glasses of water per day. They were free to arrange the 8-hour eating window based on personal preferences. This flexibility was expected to help the participants adapt to their individual lifestyles and to facilitate compliance with the dietary intervention.

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 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
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)

Trial Locations

Locations (1)

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