The Usefulness of Circulating Microvesicles (host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet Vs. Early Time-restricted Eating
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body composition (II)
研究概览
简要总结
The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.
详细描述
The specific objectives are:
- To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.
- Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.
- Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.
The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
triple-blind: participants, intervention researchers - except for the nutritionist in charge of diet and lifestyle counseling - and data analysts will be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 70 years old.
- •BMI ranges between 27 and 40 kg/ m
- •Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
- •Signature of the informed consent for participation in the study.
排除标准
- •Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
- •Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma).
- •Pregnancy and lactation.
- •Vegetarians or subjects subjected to an irregular diet.
- •Patients with severe eating disorders.
- •Patients with clinical symptoms and signs of infection in the previous month.
- •Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs.
- •Recent antibiotic treatment.
- •Uncontrolled alcoholism or drug abuse.
- •Rotating or nocturnal shift workers.
结局指标
主要结局
Body composition (II)
时间窗: Before and after (12 weeks) of the intervention
Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Anthropometric measurements (II)
时间窗: Before and after (12 weeks) of the intervention
Changes in body mass index (kg/m\^2);
Anthropometric measurements (V)
时间窗: Before and after (12 weeks) of the intervention
Changes neck circumference (cm)
Anthropometric measurements (III)
时间窗: Before and after (12 weeks) of the intervention
Changes waist circumference (cm)
Anthropometric measurements (IV)
时间窗: Before and after (12 weeks) of the intervention
Changes hip circumference (cm)
Brown fat
时间窗: Before and after (12 weeks) of the intervention
Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)
Anthropometric measurements (I)
时间窗: Before and after (12 weeks) of the intervention
Changes in weight (kg)
Body composition (I)
时间窗: Before and after (12 weeks) of the intervention
Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Body composition (III)
时间窗: Before and after (12 weeks) of the intervention
Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)
次要结局
- Gut and host microbiota-derived metabolites (I)(Before and after (12 weeks) of the intervention)
- Microbial composition/metagenomic(Before and after (12 weeks) of the intervention)
- Gut and host microbiota-derived metabolites (III)(Before and after (12 weeks) of the intervention)
- Entero-endocrine incretin hormones (I)(Before and after (12 weeks) of the intervention)
- Entero-endocrine incretin hormones (II)(Before and after (12 weeks) of the intervention)
- Gut and host microbiota-derived metabolites (II)(Before and after (12 weeks) of the intervention)
- Cellular energy metabolism(Before and after (12 weeks) of the intervention)
- Entero-endocrine incretin hormones (III)(Before and after (12 weeks) of the intervention)
- Entero-endocrine incretin hormones (IV)(Before and after (12 weeks) of the intervention)