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

NCT ID: NCT06597708

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-06-30

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.

Conditions

Gingivitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

keto diet

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

intermittent fasting with calorie restriction

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Mustansiriyah University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Thamer Kadhum

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Mustansiriyah

Baghdad, Street 6, Iraq

Countries

Iraq

Other Identifiers

MUPRV010

Identifier Type: -

Identifier Source: org_study_id