GingivitisEarly Phase 1NCT06597708
Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers
A Early Phase 1 study testing keto diet and intermittent fasting with calorie restriction in people with Gingivitis, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- keto diet and intermittent fasting with calorie restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2024to 30 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Use of anti-inflammatory and antibiotic drugs during the last month before the examination.
- Smoking.
- Use of dietary supplements.
- Wearing orthodontics or prosthodontics appliances.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- keto diet, intermittent fasting with calorie restriction
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keto dietBehavioural
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 restrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: intermittent fasting with calorie restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of keto diet on oral health
effect of keto diet on oral health by measuring the plaque index and bleeding on probing index
Measured: 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
Measured: 30 days
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 30 days
The effect of intermittent fasting on bodyweight
The effect of intermittent fasting on bodyweight loss for overweight and obese cl I participants
Measured: 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
Measured: 30 days
The effect of keto diet on salivary PH
The effect of keto diet on salivary PH ( an increase or decrease)
Measured: 30 days
The effect of intermittent fasting on salivary PH
The effect of intermittent fasting on salivary PH ( an increase or decrease)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Thamer Kadhum, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597708
- Sponsor's protocol ID
- MUPRV010
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT06597708
- Acronym / sponsor ID
- MUPRV010
- Conditions
- Gingivitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participants committed to keto diet | Active comparator | Behavioral: keto dietThe 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. |
| participants committed to intermittent fasting with calorie restriction | Active comparator | Behavioral: intermittent fasting with calorie restrictionThe 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| keto dietThey 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. | Behavioural | participants committed to keto diet |
| intermittent fasting with calorie restrictionThe 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. | Behavioural | participants committed to intermittent fasting with calorie restriction |
Primary outcome
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
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
8 secondary outcomes
The effect of keto diet on salivary inflammatory biomarkers
Time frame: 30 days
The effect of intermittent fasting on salivary inflammatory biomarkers
Time frame: 30 days
comparing the effect of KD and IF on inflammatory biomarkers
Time frame: 30 days
comparing the effect of KD and IF on oral health
Time frame: 30 days
The effect of intermittent fasting on bodyweight
Time frame: 30 days
The effect of keto diet on bodyweight loss
Time frame: 30 days
The effect of keto diet on salivary PH
Time frame: 30 days
The effect of intermittent fasting on salivary PH
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing keto diet and intermittent fasting with calorie restriction in people with Gingivitis, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of keto diet on oral health (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.