Insulin ResistanceNCT06911879
The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults
A study testing Ketogenic diet with caloric restriction, Normal diet with caloric restriction and Normal diet without caloric restriction in people with Insulin Resistance and Metabolic Endotoxemia, run by University of Jordan at 1 site in Jordan.
Trial summary
Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Insulin Resistance, Metabolic Endotoxemia, Inflammation Biomarkers
- What is being tested?
- Ketogenic diet with caloric restriction, Normal diet with caloric restriction and Normal diet without caloric restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteJordan
- Study dates
- 5 May 2025to 5 Aug 2025
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Males and females individuals aged 18-40 years
- Individuals with a body mass index (BMI) greater than 30 kg/m² and less than 40 kg/m².
- Individuals medically diagnosed with prediabetes by a physician prior to enrollment in the study as indicated by hemoglobin A1c (HbA1c) levels between 5.7% and 6.4% (American Diabetes Association, 2024), or HOMA-IR score of greater than 1.8.
- Individuals demonstrating a willingness to follow the dietary protocol
- Individuals engaging in sedentary physical activity levels
Who cannot join
- Individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus.
- Individuals have experienced weight loss of more than 5% in the last three months.
- Pregnant or lactating women.
- Individuals undergoing any form of drug treatment.
- Individuals with a history of major surgery.
- Individuals have consumed pro-/pre/symbiotic or antibiotics in the past three months.
- Individuals who engage in any form of regular sports activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ketogenic-Caloric Restricted Dietary Intervention on Metabolic Endotoxemia Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Clinical Trial
Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited.
This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.
- Conditions
- Insulin Resistance, Metabolic Endotoxemia, Inflammation Biomarkers, Ketogenic Diet, Caloric Restriction, Obesity
- Being tested
- Ketogenic diet with caloric restriction, Normal diet with caloric restriction, Normal diet without caloric restriction
- Keywords
- ketogenic diet, Ketogenic-Caloric Restricted Diet, metabolic endotoxemia, insulin resistance, obesity, prediabetes, inflammation
- Medical subject headings
- Insulin Resistance, Obesity, Prediabetic State, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic diet with caloric restrictionOther
Participants in this group will follow a ketogenic diet with caloric restriction (-550 kcal/day), consisting of approximately 5-10% carbohydrates, 15-25% protein, 70-80% fat. The daily carbohydrate intake will be limited to less than 50g per day. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks.
Normal diet with caloric restrictionOther
Participants in this group will follow a normal diet with caloric restriction (-550 kcal/day), consisting of approximately 45-60% carbohydrates, 15-25% protein, 20-30% fat. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks.
Normal diet without caloric restrictionOther
Participants in this group will follow a normal diet without caloric restriction, consisting of approximately 45-60% carbohydrates, 15-25% protein, 20-30% fat. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet with caloric restriction | Experimental | Not described Receives: Other: Ketogenic diet with caloric restriction |
| Normal diet with caloric restriction | Active comparator | Not described Receives: Other: Normal diet with caloric restriction |
| Normal diet without caloric restriction | Active comparator | Not described Receives: Other: Normal diet without caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Lipopolysaccharides (LPS) Levels
Serum LPS levels will be measured using ELISA before and after the dietary intervention to assess the impact of ketogenic-caloric restricted diet on metabolic endotoxemia in adult participants with obesity and insulin resistance."
Measured: Baseline and after 12 weeks of intervention
Secondary outcomes (11)
TNF-α, IL-6 serum levels
Serum TNF-α and IL-6 levels will be measured using ELISA at baseline and after 12 weeks to assess the inflammatory response to dietary interventions.
Measured: Baseline and after 12 weeks of intervention
Change in Fasting Glucose Level
Fasting glucose will be measured to assess glycemic control before and after the dietary intervention.
Measured: Baseline and after 12 weeks of intervention
Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)
Lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be analyzed at baseline and post-intervention to determine the impact of dietary modifications on lipid metabolism.
Measured: Baseline and after 12 weeks of intervention
Ketone bodies
ketone bodies will be measured to assess the adherence to ketogenic diet (just for arm 1) levels at week 6 and after 12 weeks of intervention."
Measured: week 6 and after 12 weeks of intervention
Change in Body weight in kilograms
Body weight in kilograms will be measured using a calibrated digital scale (InBody 120) while participants are wearing light clothing and no shoes. Measurements will be taken every two weeks throughout the 12-week intervention period.
The average weight will be recorded at each time point, and changes from baseline will be analyzed across intervention groups.
Measured: Baseline and every 2 weeks until week 12
Dietary Intake using Food Records
Measured: week4, week 8 and week 12
Change in Fasting Insulin Level
Fasting insulin will be measured to evaluate insulin levels at baseline and after 12 weeks of intervention
Measured: Baseline and after 12 weeks of intervention
Change in HOMA-IR Index
HOMA-IR index will be calculated using fasting insulin and glucose levels to evaluate changes in insulin resistance.
Measured: Baseline and after 12 weeks of intervention
Height in meters
Height in meters will be measured using a stadiometer with participants standing without shoes, feet flat, and head positioned in the Frankfurt plane. The measurement will be recorded to the nearest 0.1 cm.
The average height will be calculated for each group at baseline and used for descriptive comparison and used for BMI calculations.
Measured: Baseline only
Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)
Body composition, including body fat percentage and lean body mass, will be measured using a validated bioelectrical impedance analysis (BIA) device (InBody 120). Measurements will be conducted with participants fasting, at baseline and every 2 weeks during the 12-week intervention period.
The mean and standard deviation for each variable will be calculated at each time point and compared between intervention groups over time.
Measured: Baseline and every 2 weeks until week 12
Body Mass Index (BMI) in kg/m²
BMI will be calculated using the standard formula: weight (in kilograms) divided by the square of height (in meters) [kg/m²]. Weight and height will be measured using calibrated digital scales and stadiometers, respectively, with participants wearing light clothing and no shoes.
The mean BMI will be calculated at each time point, and changes from baseline will be compared between intervention groups.
Measured: Baseline and every 2 weeks until week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start5 May 2025
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aseel Basem jawamis, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911879
- Sponsor's protocol ID
- 381/2025
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Data access is restricted to the research team to ensure confidentiality and compliance with ethical guidelines.
Publications
Jawamis A, Al-Domi H, Sarayreh NA. Effects of the ketogenic-caloric restricted diet on metabolic endotoxemia and metabolic health in adults with prediabetes: A randomized controlled trial. Nutrition. 2026 Jun;146:113119. doi: 10.1016/j.nut.2026.113119. Epub 2026 Jan 23.
PubMed 41747400
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketogenic-Caloric Restricted Dietary Intervention on Metabolic Endotoxemia Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06911879
- Acronym / sponsor ID
- 381/2025
- Conditions
- Insulin Resistance, Metabolic Endotoxemia, Inflammation Biomarkers, Ketogenic Diet, Caloric Restriction, Obesity
- Keywords
- ketogenic diet, Ketogenic-Caloric Restricted Diet, metabolic endotoxemia, insulin resistance, obesity, prediabetes, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 4 Apr 2025 (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.
Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited.
This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet with caloric restriction | Experimental | Other: Ketogenic diet with caloric restriction |
| Normal diet with caloric restriction | Active comparator | Other: Normal diet with caloric restriction |
| Normal diet without caloric restriction | Active comparator | Other: Normal diet without caloric restriction |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Males and females individuals aged 18-40 years
Key exclusion criteria (7 listed)
- Individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus.
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 |
|---|---|---|
| Ketogenic diet with caloric restrictionParticipants in this group will follow a ketogenic diet with caloric restriction (-550 kcal/day), consisting of approximately 5-10% carbohydrates, 15-25% protein, 70-80% fat. The daily carbohydrate intake will be limited to less than 50g per day. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks. | Other | Ketogenic diet with caloric restriction |
| Normal diet with caloric restrictionParticipants in this group will follow a normal diet with caloric restriction (-550 kcal/day), consisting of approximately 45-60% carbohydrates, 15-25% protein, 20-30% fat. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks. | Other | Normal diet with caloric restriction |
| Normal diet without caloric restrictionParticipants in this group will follow a normal diet without caloric restriction, consisting of approximately 45-60% carbohydrates, 15-25% protein, 20-30% fat. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks. | Other | Normal diet without caloric restriction |
Primary outcome
Serum Lipopolysaccharides (LPS) Levels
Time frame: Baseline and after 12 weeks of intervention
Serum LPS levels will be measured using ELISA before and after the dietary intervention to assess the impact of ketogenic-caloric restricted diet on metabolic endotoxemia in adult participants with obesity and insulin resistance."
11 secondary outcomes
TNF-α, IL-6 serum levels
Time frame: Baseline and after 12 weeks of intervention
Change in Fasting Glucose Level
Time frame: Baseline and after 12 weeks of intervention
Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)
Time frame: Baseline and after 12 weeks of intervention
Ketone bodies
Time frame: week 6 and after 12 weeks of intervention
Change in Body weight in kilograms
Time frame: Baseline and every 2 weeks until week 12
Dietary Intake using Food Records
Time frame: week4, week 8 and week 12
Change in Fasting Insulin Level
Time frame: Baseline and after 12 weeks of intervention
Change in HOMA-IR Index
Time frame: Baseline and after 12 weeks of intervention
Height in meters
Time frame: Baseline only
Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)
Time frame: Baseline and every 2 weeks until week 12
Body Mass Index (BMI) in kg/m²
Time frame: Baseline and every 2 weeks until week 12
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 5 May 2026.
- Derived from this study: PubMed 41747400Jawamis A, Al-Domi H, Sarayreh NA. Effects of the ketogenic-caloric restricted diet on metabolic endotoxemia and metabolic health in adults with prediabetes: A randomized controlled trial. Nutrition. 2026 Jun;146:113119. doi: 10.1016/j.nut.2026.113119. Epub 2026 Jan 23.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Data access is restricted to the research team to ensure confidentiality and compliance with ethical guidelines.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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 study testing Ketogenic diet with caloric restriction, Normal diet with caloric restriction and Normal diet without caloric restriction in people with Insulin Resistance and Metabolic Endotoxemia, run by University of Jordan at 1 site in Jordan.
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 5 inclusion and 7 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 5 May 2026. 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 Jordan. 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.
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?
Serum Lipopolysaccharides (LPS) Levels (time frame: Baseline and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911879, which also lists 1 linked publication.
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 5 May 2026.