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Completed

NCT Number: NCT06597708

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Mustansiriyah

Baghdad, Street 6, 10011, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Keto Diet

Behavioral

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.

intermittent fasting with calorie restriction

Behavioral

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.

Primary outcomes

  1. effect of keto diet on oral health

    Time frame: 30 days

    effect of keto diet on oral health by measuring the plaque index and bleeding on probing index

  2. effect of intermittent fasting on oral health

    Time frame: 30 days

    effect of intermittent fasting on oral health by measuring the plaque index and bleeding on probing index

Secondary outcomes

  1. The effect of keto diet on salivary inflammatory biomarkers

    Time frame: 30 days

    effect of keto diet on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)

  2. The effect of intermittent fasting on salivary inflammatory biomarkers

    Time frame: 30 days

    effect of intermittent fasting on salivary inflammatory biomarkers ( IL-6, IL-1B, C-RP, TNF-A, LL-37)

  3. comparing the effect of KD and IF on inflammatory biomarkers

    Time frame: 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)

  4. comparing the effect of KD and IF on oral health

    Time frame: 30 days

    comparing the effect of KD and IF on oral health by measuring the plaque index and bleeding on probing index

  5. The effect of intermittent fasting on bodyweight

    Time frame: 30 days

    The effect of intermittent fasting on bodyweight loss for overweight and obese cl I participants

  6. The effect of keto diet on bodyweight loss

    Time frame: 30 days

    The effect of keto diet on bodyweight loss for overweight and obese cl I participants

  7. The effect of keto diet on salivary PH

    Time frame: 30 days

    The effect of keto diet on salivary PH ( an increase or decrease)

  8. The effect of intermittent fasting on salivary PH

    Time frame: 30 days

    The effect of intermittent fasting on salivary PH ( an increase or decrease)

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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