The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05558488
• Other study ID #: KETOPROJEKT2019*2023
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Poznan University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Fat Disorder
• Body Weight
• Carbohydrate Metabolism Disorder
• Disease
• Glucose Metabolism Disorders
• Immunologic Factors
• Insulin Resistance
• Insulin Sensitivity
• Insulin Tolerance
• Ketoses, Metabolic
• Ketosis
• Lipid Metabolism Disorders
• Metabolic Diseases
• Oxidative Stress
• Somatic Disorders
• Trimethylamine N-oxide

Intervention

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 (1.8gxKg-1xbody weight-1xday-1) with three meals a day. The distribution of macronutrients during the very low carbohydrate ketogenic diet (KD) was: protein 1.8 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.

Locations

Country	Name	City	State
Poland	Poznan University of Physical Education	Poznan	Wielkopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Katarzyna Siedzik

Country where clinical trial is conducted

Poland, 

References & Publications (7)

Balasse EO, Féry F. Ketone body production and disposal: effects of fasting, diabetes, and exercise. Diabetes Metab Rev. 1989 May;5(3):247-70. Review. — View Citation

Dashti HM, Mathew TC, Hussein T, Asfar SK, Behbahani A, Khoursheed MA, Al-Sayer HM, Bo-Abbas YY, Al-Zaid NS. Long-term effects of a ketogenic diet in obese patients. Exp Clin Cardiol. 2004 Fall;9(3):200-5. — View Citation

Paoli A, Bosco G, Camporesi EM, Mangar D. Ketosis, ketogenic diet and food intake control: a complex relationship. Front Psychol. 2015 Feb 2;6:27. doi: 10.3389/fpsyg.2015.00027. eCollection 2015. Review. — View Citation

Paoli A, Grimaldi K, Toniolo L, Canato M, Bianco A, Fratter A. Nutrition and acne: therapeutic potential of ketogenic diets. Skin Pharmacol Physiol. 2012;25(3):111-7. doi: 10.1159/000336404. Epub 2012 Feb 11. Review. — View Citation

Paoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26. Review. Erratum in: Eur J Clin Nutr. 2014 May;68(5):641. — View Citation

Phinney SD. Ketogenic diets and physical performance. Nutr Metab (Lond). 2004 Aug 17;1(1):2. — View Citation

Veech RL. The therapeutic implications of ketone bodies: the effects of ketone bodies in pathological conditions: ketosis, ketogenic diet, redox states, insulin resistance, and mitochondrial metabolism. Prostaglandins Leukot Essent Fatty Acids. 2004 Mar;70(3):309-19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 weeks
Primary	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	2 weeks
Primary	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)	2 weeks
Primary	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)	2 weeks
Primary	glucose level (blood, urine)	glucose level (blood, urine) - measured by Ketodiastix and Optimum Xido Neo; higher scores mean a worse outcome	2 weeks
Primary	ketone bodies (blood, urine)	ketone bodies (blood, urine) - measured by Ketodiastix and Optimum Xido Neo; higher scores mean a better outcome	2 weeks
Primary	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	2 weeks
Primary	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	2 weeks
Primary	markers of oxidative stress 2	markers of oxidative stress - concentration of protein thiol group; higher scores mean a worse outcome	2 weeks
Primary	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	2 weeks
Primary	somatic disorders	Somatic disorders measured by questionnaire based on Likert's scale; Likert's scale: - Strongly disagree; - Disagree; - Neither agree nor disagree; - Agree; - Strongly agree; It depends on question - higher scores mean a better or worse outcome	2 weeks