Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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)Masking Description: Since no placebo was found, the subjects will know the treatment they are receiving in each case. Nevertheless, the outcome assessor will not know to which treatment corresponds each sample.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 70 years
- Gender
- Both males and females
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, subje...
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.
Tracking Information
- NCT #
- NCT04383639
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Investigators
- Not Provided
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