Energy -Sensing Metabolites in Caloric Restriction
Condition: Obesity; Insulin Sensitivity/Resistance; Diabetes Type 2
MeSH terms: Obesity; Insulin Resistance; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      To investigate whether IF is better than 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 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).
    

Intervention name(s): dietary intervention
Intervention type(s): Other
Intervention description(s): Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: clinical study: randomized, cross-over design, study participants will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; diabetes; intermittent fasting; energy-sensing metabolites