Clinical trial NCT05558488: The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response
Official title: Effect of a Meatless,Ketogenic Restrictive Diet on Body Composition, Concentration of Trimethylamine N-Oxide (TMAO),Ketone Bodies and Glucose in Blood and Urine, Somatic Disorders, Strength Capacity, Oxidative Stress, Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Oxidative Stress
Trimethylamine N-oxide
Immunologic Factors
Glucose Metabolism Disorders
Insulin Resistance
Insulin Sensitivity
Insulin Tolerance
Carbohydrate Metabolism Disorder
Lipid Metabolism Disorders
Body Fat Disorder
Ketosis
Ketoses, Metabolic
Somatic Disorders
Keywords: ketogenic diet
ketosis
oxidative stress
immune response
insulin resistance
body composition
strength capacity
omega 3 acids
meatless diet
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 14
Sex: ALL
Minimum age (years): 32
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant received a nutritional plan that was the same qualitatively but differed quantitatively. It was calculated for each individual based on the Mifflin-St Jeor Equation (Basal Metabolic Rate).

After that, the levels of physical activity (PAL) were used to assess physical activity patterns and energy expenditure of individuals for placement into one of four PAL categories: sedentary, low active, active, or very active. That helped to calculate EER and made an individual reduction (minus 500 kcal / day). Before the start of the study, each participant obtained information about the basic principles of the ketogenic diet. Diet was designed to be isoproteic (1.8 g x Kg- 1 x body weight- 1 x day-1) with three meals a day. The distribution of macronutrients during the ketogenic diet (KD) was: protein 1.8 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%).
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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:

* body composition (DEXA)- Isometric muscle strength (Biodex)
* blood tests (lipid profile, glucose, insulin, ketone bodies)
* inflammatory markers - 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) (including IFN-y, IL-6, IL-8, IL-10, TNF-a, IL-2, IL-4)
* metabolic panel - Luminex method with the use of BioRad BioPlex 200 readerm (Bio-Plex Pro ™ Human Diabetes 10-Plex Assay # M171A7001M, BIO-RAD, USA) (including ghrelin, glucagon, insulin, leptin, resistin)
* markers of oxidative stress - 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)
* markers of oxidative stress (concentration of protein thiol groups)
* TMAO (trimethylamine N-oxide)

Eligibility criteria: Inclusion Criteria:

* male or female
* healthy
* age 32 - 59
* non-smoker
* not abusing alcohol
* not subjected to physical exercise for at least 48 hours before the examination

Exclusion Criteria:

* cardiovascular,
* thyroid disease,
* gastrointestinal,
* respiratory
* or any other metabolic diseases adherence to special diets, use of nutritional supplements and use of medication to control blood lipids or glucose

Primary outcomes:
measure: Body composition
timeFrame: 2 weeks
measure: Body weight
timeFrame: 2 weeks
measure: TMAO
timeFrame: 2 weeks
measure: Lipids level (TC, HDL, LDL, TG)
timeFrame: 2 weeks
measure: glucose level (blood, urine)
timeFrame: 2 weeks
measure: ketone bodies (blood, urine)
timeFrame: 2 weeks
measure: inflammatory markers
timeFrame: 2 weeks
measure: markers of oxidative stress 1
timeFrame: 2 weeks
measure: markers of oxidative stress 2
timeFrame: 2 weeks
measure: metabolic panel - diabetes
timeFrame: 2 weeks
measure: somatic disorders
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Physical Education
state: Wielkopolskie
Study officials:
affiliation: Poznan University of Physical Education, Poznan, Poland
name: Katarzyna Siedzik, MSc
role: PRINCIPAL_INVESTIGATOR
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