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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
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:
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •age 32 - 59
- •non-smoker
- •not abusing alcohol
- •not subjected to physical exercise for at least 48 hours before the examination
排除标准
- •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
结局指标
主要结局
Body composition
时间窗: 2 weeks
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)
Lipids level (TC, HDL, LDL, TG)
时间窗: 2 weeks
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)
glucose level (blood, urine)
时间窗: 2 weeks
glucose level (blood, urine) - measured by Ketodiastix and Optimum Xido Neo higher scores mean a worse outcome
ketone bodies (blood, urine)
时间窗: 2 weeks
ketone bodies (blood, urine) - measured by Ketodiastix and Optimum Xido Neo higher scores mean a better outcome
Body weight
时间窗: 2 weeks
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
inflammatory markers
时间窗: 2 weeks
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
TMAO
时间窗: 2 weeks
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)
somatic disorders
时间窗: 2 weeks
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
markers of oxidative stress 1
时间窗: 2 weeks
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
markers of oxidative stress 2
时间窗: 2 weeks
markers of oxidative stress - concentration of protein thiol group higher scores mean a worse outcome
metabolic panel - diabetes
时间窗: 2 weeks
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
次要结局
未报告次要终点
研究者
Katarzyna Siedzik
Principal Investigator
Poznan University of Physical Education