An interventional study of Meatless, restrictive ketogenic diet in Body Weight, Oxidative Stress and Trimethylamine N-oxide, sponsored by Katarzyna Siedzik. Completed at 1 site in Poland. Open to participants aged 32 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Katarzyna Siedzik · Not applicable, Interventional, and Basic science
Among 27 studies in Insulin Resistance with a site in Poland — 4 open to participants now, 4 under way, none of them phase 3. Insulin Resistance · Poland.
Among the 27 studies in Insulin Resistance with a site in Poland, this one is the 20th largest by enrollment of the 21 interventional ones that give a count, is one of 2 that started in 2019, is one of 12 with no phase, and was the 19th registered.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
Browse Insulin Resistance studies →4 of the 27 studies in Insulin Resistance with a site in Poland are open now. Recruiting first, the newest first:
University of Applied Sciences in Nowy Targ · Sites in Poland
Jagiellonian University · Sites in Poland
Jagiellonian University · Sites in Poland
Jagiellonian University · Sites in Poland
A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →
Of the 244 Insulin Resistance studies recruiting now, 54 (22%) set no upper age limit and 158 (65%) stop at 75 or younger; 30 take children under 18; 113 take healthy volunteers.
This study: 32 Years to 59 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2019.
This study's enrollment of 14 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Median enrollment 78 across the 21 interventional studies, 155 across the 6 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
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5 of 27 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Katarzyna Siedzik as lead sponsor.
Katarzyna Siedzik has 1 study filed under Insulin Resistance — fewer than ten, so there is no comparison to draw.
1 of the studies in Insulin Resistance with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07917364University of Applied Sciences in Nowy TargAsprosin and miRNA Expression in Young Women With Metabolic Syndrome | 2027-03 |
Among the 27 studies in Insulin Resistance with a site in Poland, from their registry updates:
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The subject of doctoral dissertation: Assessment of the effects of a meatless, ketogenic restrictive diet on body composition, strength capacity, oxidative stress and immune response
During planning of research and topic of the doctoral dissertation, it was considered how to modify a standard ketogenic diet rich in saturated fatty acids so that the use of this model of nutrition has the most anti-inflammatory effect. Therefore, it was decided to conduct a research to check whether a diet rich in omega-3 polyunsaturated fatty acids will show such an effect when following a high-fat diet.
Hypotheses:
1. The ketogenic diet reduces systemic inflammation. 2.The ketogenic diet reduces oxidative stress. 3. The ketogenic diet reduces body fat. 4. A ketogenic diet does not worsen strength performance.
a) main research assumption
Reports in the international literature regarding the importance of the ketogenic diet are ambiguous. Some researchers believe that its use reduces body fat and improves insulin sensitivity or lipid profile, while others question this view and question it. Many authors emphasized the need for further research in this area, and this outline of the research project responds to this postulate.
In the presented experiment, the duration of a single experiment was 14 days, because the individual adaptation period of each participant should be taken into account - the so-called "keto-adaptation".
In order to assess the effectiveness of the nutritional intervention in this experiment, the following were performed: blood sampling for the determination of basic parameters (lipid profile, fasting glucose, fasting insulin, diabetic panel, hormones), determination of glucose and ketone bodies (β ketones) in the blood using a strip test - Optium Xido Neo glucometer, determination of the concentration of ketone bodies (acetoacetic acid) and glucose in the urine using Keto-Diastix - a strip test, examination by means of tests - force (maximum isokinetic force test with the use of Biodex apparatus), determination of inflammatory markers (TNF alpha, pro-inflammatory, anti-inflammatory and pro-or anti-inflammatory interleukins depending on the conditions), determination of oxidative stress markers - related to free radical damage to proteins (carbonyl groups, sulfhydryl groups (SH groups)), body composition measurement using the DEXA method (Dual Energy X-ray Absorptiometry). Choosing this method instead of the very common bioimpedance, due to the fact that using densitometry, it obtained very precise results of adipose tissue.
The above-described procedures were used to check the molecular basis of the phenomenon under study, to determine the parameters in which significant changes are visible and to determine the extent to which they translate into the function of the muscle and the subjective feelings of the subject.
Research methodology:
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →This is the only study on the registry with Katarzyna Siedzik as lead sponsor.
Compared within Insulin Resistance, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diet was designed to be isoproteic (1.6 g x Kg- 1 x body weight- 1 x day-1) with three meals a day., restrictive (EER minus 500 kcal / day). The distribution of macronutrients during the very low carbohydrate ketogenic diet (KD) was: protein 1.6 g x Kg-1 x body weight- 1 x day-1 (\~ 25-30%), fats (\~ 65-70%, with a strong emphasis on the content of omega 3 fatty acids) and carbohydrate (\< 30 g x day- 1; \< 10%).
Other: Meatless, restrictive ketogenic diet
Each participant received a nutritional plan that was the same qualitatively but differed quantitatively - a 500 kcal reduction based on Estimated Energy Requirement (EER) was assumed. Before the start of the study, each participant obtained information about the basic principles of the ketogenic diet. Diet was designed to be isoproteic (1.6gxKg-1xbody weight-1xday-1) with three meals a day. The distribution of macronutrients during the very low carbohydrate ketogenic diet (KD) was: protein 1.6 gxKg-1xbody weight-1xday-1(\~25-30%), fats (\~65-70%,with a strong emphasis on the content of omega 3 fatty acids) and carbohydrate (\<30gxday-1;\<10%). The food lists encouraged the consumption of fish,raw and cooked vegetables, eggs,fruits with the lowest glycemic index (blueberry, raspberry), plant oils and fats from avocado,olives.Drinks permitted were tea, coffee without sugar and the foods and drinks to be avoided were alcohol,meat (any kind of meat),bread,pasta,rice,milk,dairy and potatoes.
Body composition
Whole body and regional body composition were measured in the morning after a 12 hours overnight fast by dual energy X-ray absorptiometry (DEXA) Body Composition: Body Fat Mass, Fat Free Mass, and Visceral Body Fat Body Fat Mass \[Kg\] max 40.143 Kg min 11.129 Kg (higher scores mean a worse outcome) Fat Free Mass \[Kg\] max 68.527 Kg min 37.72 Kg (higher scores mean a better outcome) Visceral Body Fat \[g\] max 2139 g min 90 g (higher scores mean a worse outcome)
Time frame: 2 weeks
Body weight
Body weight was measured with an accuracy of 0.1 Kg using an electronic scale (Tanita BC-601, Japan) Body weight (higher scores mean a worse outcome) \[Kg\] max 95.7 Kg min 60.9 Kg
Time frame: 2 weeks
TMAO
Trimethylamine N-Oxide (measured by Institute of Biochemistry and Biophysics Polish Academy of Sciences, Warsaw Poland) TMAO \[ng/ml\] (higher scores mean a worse outcome)
Time frame: 2 weeks
Lipids level (TC, HDL, LDL, TG)
Level of lipids - (TC- Total Cholesterol, LDL- low-density lipoprotein, HDL- high-density lipoprotein, TG - triacylglycerol) TC \[mg/dl\] (higher scores mean a worse outcome) LDL \[mg/dl\] (higher scores mean a worse outcome) TG \[mg/dl\] (higher scores mean a worse outcome) HDL \[mg/dl\] (higher scores mean a better outcome)
Time frame: 2 weeks
glucose level (blood, urine)
glucose level (blood, urine) - measured by Ketodiastix and Optimum Xido Neo higher scores mean a worse outcome
Time frame: 2 weeks
ketone bodies (blood, urine)
ketone bodies (blood, urine) - measured by Ketodiastix and Optimum Xido Neo higher scores mean a better outcome
Time frame: 2 weeks
inflammatory markers
inflammatory markers (including IFN-y, IL-6, IL-8, IL-10, TNF-a, IL-2, IL-4) - Luminex method with the use of BioRad BioPlex 200 reader Pro and anti-inflammatory cytokines (Bio-Plex Pro ™ Human Cytokine 8-plex Assay M50000007A, BIO-RAD, USA) depends - higher scores mean a better or worse outcome
Time frame: 2 weeks
markers of oxidative stress 1
markers of oxidative stress - concentration of protein carbonyl groups - Colorimetric method; Plate-based colorimetric measurement (360-385 nm) (concentration of protein carbonyl groups: Protein Carbonyl Colorimetric Assay Kit No. 100005020 (Cayman Chemical, Ann Arbor, MI, USA) higher scores mean a worse outcome
Time frame: 2 weeks
markers of oxidative stress 2
markers of oxidative stress - concentration of protein thiol group higher scores mean a worse outcome
Time frame: 2 weeks
metabolic panel - diabetes
metabolic panel - diabetes (including ghrelin, glucagon, insulin, leptin, resistin) - Luminex method with the use of BioRad BioPlex 200 readerm (Bio-Plex Pro ™ Human Diabetes 10-Plex Assay # M171A7001M, BIO-RAD, USA) depends - higher scores mean a better or worse outcome
Time frame: 2 weeks
somatic disorders
Somatic disorders measured by questionnaire based on Likert's scale Likert's scale: 1. \- Strongly disagree 2. \- Disagree 3. \- Neither agree nor disagree 4. \- Agree 5. \- Strongly agree It depends on question - higher scores mean a better or worse outcome
Time frame: 2 weeks
Plan to share: No
Ran from Oct 2019 to primary completion in Jun 2021, 20 months.
Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 20 months is close to that.
Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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