New Energy-sensing Metabolites: Beneficial Effects on Metabolic Health in Obesity Comparing Diary Caloric Restriction vs Intermittent Fasting. A Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin)
研究概览
简要总结
General integrated goal of the coordinated project:
To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids (SCFAs), as energy sensing metabolites in the context of obesity and type 2 diabetes (T2D).
Specific objectives of Subproject 1 (SP1): 1a. - To investigate whether intermittent fasting (IF) is better than Continued Daily Caloric Restriction (DCR) in terms of metabolic improvement through the study of: 1) the dynamics of gastrointestinal hormones and energy sensing metabolites, 2) the intestinal microbiome, 3) variability on succinate and SCFAs, MCFAs and Biliary Acid after weight loss; Methodology: clinical study: randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Clinical, anthropometrical and functional studies. Metabolomics for gut derived metabolites in plasma. Enteroendocrine gastrointestinal dynamics. Metagenomic analysis.
详细描述
To investigate whether IF is better than DCR in terms of metabolic improvement through the study of:
- the dynamics of gastrointestinal hormones and energy sensing metabolites
- the intestinal microbiome
- variability on succinate and SCFAs MCFAs and BA after weight loss
Human study protocol:
A pilot clinical trial in human study participants will be assayed. Participants for intermittent fasting (IF) will be asked to fast for 24 hours on two days of the week (2/5 protocol).
1A.-Design: Utilizing a randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Each study period will be 8 weeks - total study period will be 16 weeks + a 4-week washout period between dietary exposures. The study participants will be adults who have obesity with a Body Mass Index (BMI)25 kg/m2 and 40 kg/m2 and have no contraindications for intermittent fasting (see inclusion and exclusion criteria below).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •White men and women between 18 and 65 years of age.
- •BMI range between 25 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.
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.
- •Psychiatric history.
- •Uncontrolled alcoholism or drug abuse.
结局指标
主要结局
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin)
时间窗: basal and after 8 weeks
Plasma concentrations of insulin during a meal test
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin after crossing arm)
时间窗: at beginning of week 12 vs week 20
Plasma concentrations of insulin during a meal test
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose)
时间窗: basal and after 8 weeks
Plasma concentrations of glucose during a meal test
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose after crossing arm)
时间窗: at beginning of week 12 vs week 20
Plasma concentrations of glucose during a meal test
次要结局
- 2) Analysis of microbial species in fecal samples (gut flora)(8 weeks - 20 weeks)
- 1) the dynamics of gastrointestinal hormones and energy sensing metabolites(8 weeks - 20 weeks)
- variability on succinate after weight loss(8 weeks - 20 weeks)
- variability on Medium-chain fatty acids (MCFAs) after weight loss(8 weeks - 20 weeks)
- variability on biliary acids (BA) after weight loss(8 weeks - 20 weeks)
- variability on Short-chain fatty acids (SCFAs) after weight loss(8 weeks - 20 weeks)
研究者
Joan Josep Vendrell
professor
Institut Investigacio Sanitaria Pere Virgili