Exploring the Effects of Time-restricted Feeding on the Immune Function of Obese Individuals: Multi-omic Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Level of inflammatory cytokine IL-1β
研究概览
简要总结
The goal of this randomized trial is to: 1) investigate the immunological landscape of patients with obesity and conduct an in-depth functional characterization of their immune system; and 2) precisely define the effects of time-restricted feeding (TRF) on immune function in patients with obesity; 3) define the immunomodulatory properties of white adipocytes in response to TRF, and 4) uncover the underlying mechanisms by which TRF modulates the immune system patients with obesity through a multi-omics approach.
The main questions it aims to answer are: i) what is the underlying cause of impaired immunocompetence in patients with obesity? ii) how nutritional interventions improve the immune function of patients with obesity? Patients with obesity following TRF (8 h eating window ranging from 6-8 am to 14-16 pm) will be compared to patients with obesity without TRF control schedule (14h eating window ranging from 6-8 am to 8-10 pm). The dietary intervention will begin 10 weeks before the scheduled date for bariatric surgery in patients with obesity. In addition to patients with obesity, the present study aims to recruit a group of a reference healthy group (BMI between 18.5-24.9 kg/m²) that will not receive any nutritional intervention.
The following endpoints will be collected: Body weight and composition using Bioelectrical Impedance Analysis, resting energy expenditure (REE) using indirect calorimetry, blood glucose levels using a continuous glucose monitoring (CGM) device, metabolic parameters (fasting blood glucose levels, C-peptide, HbA1c, insulin, HOMA-IR, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, hepatic enzymes), and cytokine profile.
Blood, stool, and white adipose tissue (WAT) samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with obesity
- •Age 18-64 years
- •Body mass Index between 40-50 kg/m²
- •Scheduled bariatric surgery 10-12 weeks after the nutritional intervention
- •Self-reported eating pattern window of more than 14h
- •Three meal eating pattern
- •Stable body weight (less than 10% of current body weight during the last 3 months)
- •Patients who have a favourable decision from the multidisciplinary team meetings after multidisciplinary nutritional follow-up of at least 6 months and history of failure with non-surgical weight loss methods
- •Social security affiliation
- •Written consent
- •Good understanding of the French language
- •Lean patients
- •Age 18-64 years
- •Body mass Index between 18.5-24.9 kg/m²
- •Scheduled banal surgery in the opinion of the investigator
- •Self-reported eating pattern window of more than 14h
- •Social security affiliation
- •Written consent
- •Good understanding of the French language
排除标准
- •Diabetes type I or II
- •Major cardiovascular disease
- •Pregnancy
- •Medication that could affect the study outcomes (i.e. anti-inflammatory drugs, antibiotics, immunosuppressors)
- •Use products intended for weight loss
- •Night work shift
- •Past record of malignant tumors
- •Serious liver dysfunction or chronic kidney disease
- •Eating disorders
- •Chronic viral disease (Hepatitis B or C, HIV) or inflammatory systemic diseases (i.e. Crohn's disease, rheumatoid arthritis)
- •Serious cardiovascular or cerebrovascular disease within 6 months before randomization
- •Severe gastrointestinal diseases or gastrointestinal surgery in the 12 months before randomization
- •Under guardianship, curatorship, deprived of liberty
- •Unable or unwilling to sign the informed consent form.
- •Patient on AME (state medical aid)
结局指标
主要结局
Level of inflammatory cytokine IL-1β
时间窗: 10 weeks
The mean difference in inflammatory cytokine IL-1β in patients with obesity after 10 weeks under TRF versus patients with obesity without TRF.
次要结局
- Percent of weight change from baseline(Baseline, Week 10)
- Change in lean mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline(Baseline, Week 10)
- Change in fat mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline(Baseline, Week 10)
- Change in fasting blood glucose levels from baseline(Baseline, 10 weeks)
- Change in resting energy expenditure (kcal/day), measured using indirect calorimetry, from baseline(Baseline, 10 weeks)
- Change in fasting C-peptide levels from baseline(Baseline, 10 weeks)
- Change in HbA1c Levels from Baseline (Percentage Points)(Baseline, 10 weeks)
- Change in fasting insulin levels from baseline(Baseline, 10 weeks)
- Change in HOMA-IR from baseline(Baseline, 10 weeks)
- Change in lipid profile from baseline(Baseline, 10 weeks)
- Change in ALT and AST levels (U/L) from baseline(Baseline, 10 weeks)
- Change in Plasma Cytokine Levels from Baseline Using Luminex Assay(Baseline, 10 weeks)
- Changes in blood metabolome evaluated by gas chromatography and liquid chromatography coupled with high-resolution mass spectrometry(Baseline, 10 weeks)
- Changes in gut microbiome diversity using shotgun metagenomics(Baseline, 10 weeks)
- Changes in adipose tissue metabolome(Baseline, 10 weeks)
- Changes in gene expression profile assessed by RNA sequencing(Baseline, 10 weeks)
- Changes in blood immune cell populations measured using spectral flow cytometry(Baseline, 10 weeks)
- Changes in adipose tissue immune cell populations(Baseline, 10 weeks)