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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06597708
Enrollment
52
Registered
2024-09-19
Start date
2024-02-01
Completion date
2024-06-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

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.

Interventions

BEHAVIORALketo 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.

BEHAVIORALintermittent 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.

Sponsors

Al-Mustansiriyah University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
effect of keto diet on oral health30 dayseffect of keto diet on oral health by measuring the plaque index and bleeding on probing index
effect of intermittent fasting on oral health30 dayseffect of intermittent fasting on oral health by measuring the plaque index and bleeding on probing index

Secondary

MeasureTime frameDescription
comparing the effect of KD and IF on inflammatory biomarkers30 dayscomparing 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 health30 dayscomparing 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 bodyweight30 daysThe effect of intermittent fasting on bodyweight loss for overweight and obese cl I participants
The effect of keto diet on salivary inflammatory biomarkers30 dayseffect of keto diet on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)
The effect of keto diet on salivary PH30 daysThe effect of keto diet on salivary PH ( an increase or decrease)
The effect of intermittent fasting on salivary PH30 daysThe effect of intermittent fasting on salivary PH ( an increase or decrease)
The effect of keto diet on bodyweight loss30 daysThe effect of keto diet on bodyweight loss for overweight and obese cl I participants
The effect of intermittent fasting on salivary inflammatory biomarkers30 dayseffect of intermittent fasting on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026