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

NCT05558488 | Completed DMC

• 1 other identifier: KETOPROJEKT2019*2023
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• glucose level (blood, urine)

  glucose level (blood, urine) - measured by Ketodiastix and Optimum Xido Neo higher scores mean a worse outcome

  2 weeks

• ketone bodies (blood, urine)

  ketone bodies (blood, urine) - measured by Ketodiastix and Optimum Xido Neo higher scores mean a better outcome

  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

  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

  2 weeks

• markers of oxidative stress 2

  markers of oxidative stress - concentration of protein thiol group higher scores mean a worse outcome

  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

  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

  2 weeks

Study Arms (1)

Meatless restrictive ketogenic diet

EXPERIMENTAL

Diet was designed to be isoproteic (1.8 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 1.8 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%).

Other: Meatless, restrictive ketogenic diet

Interventions

Meatless, restrictive ketogenic diet OTHER

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.

Meatless restrictive ketogenic diet

Eligibility Criteria

• Age: 32 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Katarzyna Siedzik: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, 61-871, Poland

Location

Related Publications (7)

• Phinney SD. Ketogenic diets and physical performance. Nutr Metab (Lond). 2004 Aug 17;1(1):2. doi: 10.1186/1743-7075-1-2.

  PMID: 15507148 BACKGROUND

• 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.

  PMID: 22327146 BACKGROUND

• 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.

  PMID: 23801097 BACKGROUND

• 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.

  PMID: 25698989 BACKGROUND

• 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.

  PMID: 19641727 BACKGROUND

• 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. doi: 10.1016/j.plefa.2003.09.007.

  PMID: 14769489 BACKGROUND

• Balasse EO, Fery F. Ketone body production and disposal: effects of fasting, diabetes, and exercise. Diabetes Metab Rev. 1989 May;5(3):247-70. doi: 10.1002/dmr.5610050304.

  PMID: 2656155 BACKGROUND

MeSH Terms

Conditions

Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Lipid Metabolism Disorders; Ketosis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Acidosis; Acid-Base Imbalance

Study Officials

• Katarzyna Siedzik, MSc

  Poznan University of Physical Education, Poznan, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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%).

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: October 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)