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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Behavioral: keto diet; Behavioral: intermittent fasting with calorie restriction

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Street 6
    • Baghdad, Street 6, Iraq, 10011
      • University of Mustansiriyah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: participants committed to 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.	Behavioral: keto diet; 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.
Active Comparator: participants committed to 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of keto diet on oral health	effect of keto diet on oral health by measuring the plaque index and bleeding on probing index	30 days
effect of intermittent fasting on oral health	effect of intermittent fasting on oral health by measuring the plaque index and bleeding on probing index	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: MUPRV010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No