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
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