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Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes

NCT04383639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-08

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)

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).

Sponsors & Collaborators

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV

  • National Research Council, Spain

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2022-02-28
Completion
2023-07-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383639 on ClinicalTrials.gov