Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes

NCT04383639 | Completed

• 1 other identifier: RTI2018DIABE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Polyphenols; Type 2 diabetes; Cocoa; Carob; Postprandial response; Insulin resistance; Microbial metabolites

Outcome Measures

Primary Outcomes (1)

• Postprandial insulin

  Changes of postprandial insulin as result of supplementation with cocoa and carob

  Up to two months

Secondary Outcomes (6)

• Postprandial glucose

  Up to four months

• Postprandial triglycerides

  Up to four months

• Postprandial uric acid

  Up to four months

• Postprandial GLP-1

  Up to five months

• Postprandial phenolic metabolites

  Up to six months

Study Arms (3)

1

ACTIVE COMPARATOR

All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3).

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

2

EXPERIMENTAL

All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3).

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

3

EXPERIMENTAL

All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3).

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

Interventions

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

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).

1; 2; 3

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Council, Spain: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Breakfast; locust bean gum

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 12, 2020
• Study Start: May 3, 2021
• Primary Completion: February 28, 2022
• Study Completion: July 30, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

ES (1)