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

NCT06597708 | Completed Early Phase 1

• 1 other identifier: MUPRV010
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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
• Evaluate the impact of Keto diet and Intermittent Fasting on oral health among the Iraqi population.
• Assess changes in inflammatory biomarkers within the study groups before and after the intervention period.
• Compare the effects of Keto diet and Intermittent Fasting on oral health and inflammatory biomarkers between the two intervention groups.
• Examine the variations in oral health and inflammatory biomarkers within each group by comparing the baseline (Iraqi diet) and post-intervention stages.
• Investigate the influence of Keto diet and Intermittent Fasting on the levels of LL37, an antimicrobial peptide.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The effect of keto diet on salivary inflammatory biomarkers

  30 days

• The effect of intermittent fasting on salivary inflammatory biomarkers

  30 days

• comparing the effect of KD and IF on inflammatory biomarkers

  30 days

• comparing the effect of KD and IF on oral health

  30 days

• The effect of intermittent fasting on bodyweight

  30 days

Study Arms (2)

participants committed to keto diet

ACTIVE COMPARATOR

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

participants committed to intermittent fasting with calorie restriction

ACTIVE COMPARATOR

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

Interventions

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.

participants committed to keto diet

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.

participants committed to intermittent fasting with calorie restriction

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

University of Mustansiriyah

Baghdad, Street 6, 10011, Iraq

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IR (1)