Effects of Diets Differing in Macronutrient Composition on Gut Microbiota Composition, Intestinal Inflammation Markers, Gene Expression Profiles, and Blood Biochemical Parameters in Diverse Populations.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- β-hydroxybutyrate
研究概览
简要总结
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This 12-week randomized controlled trial will investigate the effects of dietary patterns with different macronutrient compositions on gut microbiota, intestinal inflammation, gene expression, and metabolic health in healthy adults.
Participants will be randomly assigned to one of three dietary interventions: a ketogenic diet (KD), a vegetarian diet (VD), or a control diet (CD) reflecting their habitual mixed dietary pattern. Adherence to the assigned diet will be monitored through dietary records and regular nutritional counseling.
The study will evaluate changes in gut microbiota composition, inflammatory biomarkers, transcriptomic profiles, and blood biochemical parameters associated with lipid and glucose metabolism. Blood and stool samples will be collected at predefined time points throughout the intervention, while participants in the KD group will additionally undergo ketone monitoring to assess dietary compliance.
By comparing the ketogenic and vegetarian diets with a standard mixed diet, this study aims to determine their effects on gut health, metabolic function, and systemic inflammation, thereby providing evidence to inform dietary recommendations.
Ta wersja eliminuje powtórzenia ("diet", "study", "monitor", "effects"), jest bardziej naturalna stylistycznie i odpowiada standardowi językowemu publikacji w czasopismach z zakresu żywienia i medycyny.
详细描述
This 12-week randomized controlled trial will evaluate the effects of diets differing in macronutrient composition on gut microbiota, intestinal inflammation markers, gene expression profiles, and blood biochemical parameters. All participants will undergo comprehensive measurements and laboratory assessments at four time points: before the study begins (baseline), after 4 weeks, after 8 weeks, and at 12 weeks (study completion).
At each assessment point (baseline, 4, 8, and 12 weeks), all participants will visit the laboratory in a fasting state and undergo the following measurements:
- Body mass and body composition assessment
- Transcriptomic analysis
- Cellular metabolism studies
- Biochemical blood parameters
- Gut microbiome analysis
Additionally, participants in the ketogenic diet (KD) group will measure blood ketone levels once weekly throughout the entire study period to monitor dietary adherence. All participants will complete questionnaires assessing stress levels and appetite before, during, and after the study intervention.
**Body Mass and Body Composition Measurement**
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In addition to the physical activity requirements described above, the study will include men and women aged 18-60 years with:
- •BMI not exceeding 40kg/m²
- •Habitual mixed diet prior to study enrollment
- •Normal blood pressure
排除标准
- •Poprawiłem już **Exclusion Criteria** w poprzedniej odpowiedzi - wszystkie te kryteria już tam są wpisane. Oto pełna, ostateczna wersja z wszystkimi wskazanymi kryteriami wyłączenia:
- •*** **Exclusion Criteria:**
- •Use of medications regulating **glucose levels** (e.g., metformin) or **blood lipids** (e.g., **statins**)
- •**Hypertension** or pharmacological treatment for hypertension
- •Diagnosed **gastrointestinal disorders**, including:
- •Gastric and duodenal ulcers
- •**Irritable bowel syndrome (IBS)**
- •**Ulcerative colitis**
- •**Celiac disease**
- •Chronic use of medications such as:
- •**Mesalazine**
- •**Corticosteroids**
- •**Statins**
- •**Proton pump inhibitors (PPI)**
- •**Non-steroidal anti-inflammatory drugs (NSAIDs)**
- •**Anticonceptional medications**
- •**Any supplements**
- •**Alcohol consumption** > 2 times/week with > 15 g alcohol per occasion (approximately 15 g alcohol = 330 mL beer, 150 mL dry red wine, or 50 mL vodka)
- •**Smoking cigarettes**
- •Following a **ketogenic diet** or **vegetarian diet** within **1 month** prior to study enrollment
研究组 & 干预措施
Ketogenic diet
Participants in this arm will follow a ketogenic diet characterized by high fat, very low carbohydrate, and moderate protein intake throughout the 12-week intervention period.
干预措施: Ketogenic Diet (KD) (Other)
Vegetarian Diet Group
Participants in this arm will follow a plant-based vegan diet excluding all animal products throughout the 12-week intervention period.
干预措施: Vegetarian Diet (VD) (Other)
Control Diet Group (CD)
Participants in this arm will serve as the control group and will continue their current habitual mixed diet without specific dietary modifications throughout the 12-week study period.
干预措施: Control Diet (CD) (Other)
结局指标
主要结局
β-hydroxybutyrate
时间窗: 12 weeks
mmol/L
Insulin
时间窗: 12 weeks
IU/mL
Glucose
时间窗: 12 weeks
mg/dL
Omega index
时间窗: 12 weeks
glucagon-like peptide-1
时间窗: 12 weeks
pg/mL
leptin
时间窗: 12 weeks
ng/mL
peptide YY
时间窗: 12 weeks
pg/mL
gut microbiome
时间窗: 12 weeks
CFU/g
Transcriptomic
时间窗: 12 weeks
log 2fold change
Gene Polymorphism
时间窗: 12 weeks
allel variance
Total cholesterol
时间窗: 12 weeks
mg/dL
HbA1c
时间窗: 12 weeks
Testosterone
时间窗: 12 weeks
nmol/L
Cortisol
时间窗: 12 weeks
μg/dL
HDL cholesterol
时间窗: 12 weeks
mg/dL
LDL cholesterol
时间窗: 12 weeks
mg/dL
Triacylglycerol
时间窗: 12 weeks
mg/dL
Grelin
时间窗: 12 weeks
ng/mL
cholecystokinin
时间窗: 12 weeks
pg/mL
次要结局
未报告次要终点
研究者
Małgorzata Magdalena Michalczyk
assistant professor
The Jerzy Kukuczka Academy of Physical Education in Katowice