Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this is study is to evaluate the effects of a single intake of a mixture of cacao
      and carob (rich in high molecular weight polyphenols) in postprandial metabolism in subjects
      with type 2 diabetes. Studies on the effects of polyphenols on postprandial (glucidic and
      lipidic) metabolism have commonly been performed in animal models and have used food
      extracts, ignoring high molecular weight polyphenols as relevant bioactive compounds. In this
      study, the potential of this kind of polyphenols for regulating postprandial disturbances in
      type 2 diabetes subjects, since these alterations increased the cardiovascular risk in these
      subjects, will be evaluated. The study has been designed in order to differentially evaluate
      the effect of intact polyphenols and that of microbial-derived phenolic metabolites.
    

Detailed description: 
      Twenty-five subjects with a recent diagnosis of type 2 diabetes will be recruited. Detailed
      inclusion and exclusion criteria are provided below.

      The whole intervention has been divided in 3 treatments A, B and C, performed every 2 weeks
      in randomized order for each subject. In every treatment, subjects will attend to the Unit of
      Human Nutrition of the ICTAN-CSIC in fasting state and they will receive a high-sugar
      high-fat breakfast. Treatment A will be used as control and will only consist of breakfast.
      Treatment B is characterized by the administration of a mixture of cocoa and carob solved in
      milk together with breakfast. In treatment C, volunteers will consume the same amount of
      product 10 hours before attending to their visit, where the breakfast will be administrated
      once again. Food and drinks provided in the three visits (including milk used in treatment B)
      will be similar. The aim of treatment B is to elucidate the role of intact polyphenols, while
      treatment C will evaluate the effect of microbial-derived polyphenol metabolites.

      Blood samples will be collected before breakfast and at times 60-120-180-240-270 min. Urine
      will be collected during their permanence at the Unit of Human nutrition of the ICTAN-CSIC.
      Feces will be collected as soon as they are generated after receiving treatments A and C. The
      following determinations will be performed in blood samples collected at different periods:
      glucose, insulin, triglycerides, uric acid, GLP-1, hepatic enzymes. Urine and feces will be
      used to evaluate phenolic metabolites. Additionally, a satiety test will be provided. It is
      expected that cocoa and carob supplementation, as compared to the control treatment, causes
      significant modifications in all the parameters indicated. Nevertheless, the primary outcome
      of this study is the decrease in postprandial insulin.
    

Intervention name(s): No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)
Intervention type(s): Other
Intervention description(s): The subjects will receive, after overnight fasting, a high-fat high-sugar breakfast. In treatment A, they will not receive any additional product; in treatment B, they will receive at the same time a mixture of coca and carob; in treatment C, they will receive the mixture of coca and carob 10 h before breakfast. A total of 6 blood samples will be collected during each visit: 0-30-60-120-180-240-270 min. Urine samples will be collected during the permanence of the subjects in the Unit of Human Nutrition. Feces will be collected the first time they are generated after treatments A and C. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
Intervention MeSH terms: Locust bean gum
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A: control period; B: mixture of cocoa and carob consumed together with breakfast; C: mixture of cocoa and carob consumed 10 h before breakfast. All the subjects will pass the three treatments, in randomized order. The three periods will be separated by a two weeks washing period.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polyphenols; Type 2 diabetes; Cocoa; Carob; Postprandial response; Insulin resistance; Microbial metabolites