Clinical trial NCT04383639: Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes
Official title: Evaluation of Postprandial Effects of High Molecular Weight Polyphenols in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Polyphenols
Type 2 diabetes
Cocoa
Carob
Postprandial response
Insulin resistance
Microbial metabolites
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes during the last 2 years and current treatment with metformin
* Overweight or obesity (IMC = 26-40 kg/m2)

Exclusion Criteria:

* Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
* Subjects with diagnoses of cardiovascular diseases or thyroid diseases.
* Values above the following ones: glucose, \> 125 mg/dL; triglycerides, \> 350 mg/dL; total cholesterol, \> 280 mg/dL; systolic blood pressure, \> 150 mmHg; diastolic blood pressure, \> 100 mmHg
* Previous bariatric surgery.
* Volunteers currently participating in other studies or weight loss plans.
* Pregnant or breastfeeding women.
* Adherence to vegetarian diets or usual consumption of dietary supplements.
* Intolerance or allergy to some of the foods provided in the study

Primary outcomes:
measure: Postprandial insulin
timeFrame: Up to two months
Secondary outcomes:
measure: Postprandial glucose
timeFrame: Up to four months
measure: Postprandial triglycerides
timeFrame: Up to four months
measure: Postprandial uric acid
timeFrame: Up to four months
measure: Postprandial GLP-1
timeFrame: Up to five months
measure: Postprandial phenolic metabolites
timeFrame: Up to six months
measure: Satiety measured by a Visual Analogue Scale (see "Description" for details)
timeFrame: Up to three months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Study officials:
References: