Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

Официальное название

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

Обзор

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.

Подробное описание

The specific objectives are:

1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects. 2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones. 3. 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.

Вмешательства

• Поведенческое Active Comparator: Continuous calorie restriction
  Individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention
• Поведенческое eTRE
  early (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention

Первичные конечные точки

• Anthropometric measurements (I) [Срок оценки: Before and after (12 weeks) of the intervention]
• Anthropometric measurements (II) [Срок оценки: Before and after (12 weeks) of the intervention]
• Anthropometric measurements (III) [Срок оценки: Before and after (12 weeks) of the intervention]
• Anthropometric measurements (IV) [Срок оценки: Before and after (12 weeks) of the intervention]
• Anthropometric measurements (V) [Срок оценки: Before and after (12 weeks) of the intervention]
• Body composition (I) [Срок оценки: Before and after (12 weeks) of the intervention]
• Body composition (II) [Срок оценки: Before and after (12 weeks) of the intervention]
• Body composition (III) [Срок оценки: Before and after (12 weeks) of the intervention]
• Brown fat [Срок оценки: Before and after (12 weeks) of the intervention]

Вторичные конечные точки (9)

• Gut and host microbiota-derived metabolites (I) [Срок оценки: Before and after (12 weeks) of the intervention]
• Gut and host microbiota-derived metabolites (II) [Срок оценки: Before and after (12 weeks) of the intervention]
• Gut and host microbiota-derived metabolites (III) [Срок оценки: Before and after (12 weeks) of the intervention]
• Entero-endocrine incretin hormones (I) [Срок оценки: Before and after (12 weeks) of the intervention]
• Entero-endocrine incretin hormones (II) [Срок оценки: Before and after (12 weeks) of the intervention]
• Entero-endocrine incretin hormones (III) [Срок оценки: Before and after (12 weeks) of the intervention]
• Entero-endocrine incretin hormones (IV) [Срок оценки: Before and after (12 weeks) of the intervention]
• Microbial composition/metagenomic [Срок оценки: Before and after (12 weeks) of the intervention]
• Cellular energy metabolism [Срок оценки: Before and after (12 weeks) of the intervention]

Критерии участия

Критерии включения

• age between 18 and 70 years old.
• BMI ranges between 27 and 40 kg/ m2.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario de Tarragona Juan XXIII — Tarragona

Идентификаторы

NCT: NCT06395246 · PI23/01133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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