Type 2 Diabetes Clinical Trial
— CACAOBAOfficial title:
Evaluation of Postprandial Effects of High Molecular Weight Polyphenols in Subjects With Type 2 Diabetes
NCT number | NCT04383639 |
Other study ID # | RTI2018DIABE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2021 |
Est. completion date | July 30, 2023 |
Verified date | November 2023 |
Source | National Research Council, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 30, 2023 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC) | Madrid |
Lead Sponsor | Collaborator |
---|---|
National Research Council, Spain | Ministerio de Economía y Competitividad, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postprandial insulin | Changes of postprandial insulin as result of supplementation with cocoa and carob | Up to two months | |
Secondary | Postprandial glucose | Changes of blood glucose as result of supplementation with cocoa and carob. | Up to four months | |
Secondary | Postprandial triglycerides | Changes of blood triglycerides as result of supplementation with cocoa and carob. | Up to four months | |
Secondary | Postprandial uric acid | Changes of blood uric acid as result of supplementation with cocoa and carob. | Up to four months | |
Secondary | Postprandial GLP-1 | Changes of blood GLP-1 as result of supplementation with cocoa and carob. | Up to five months | |
Secondary | Postprandial phenolic metabolites | Changes of urinary and fecal phenolic metabolites as result of supplementation with cocoa and carob. | Up to six months | |
Secondary | Satiety measured by a Visual Analogue Scale (see "Description" for details) | Changes of satiety as result of supplementation with cocoa and carob. This will be determined by the CSS, composite satiety score. This is a value obtained from a formula once the subject has filled in, in a visual analogue scale, the answer to different questions regarding hunger and satiety. The answers go from 1 to 10 (each mark corresponding to a similar distance in the scale). The final CSS value goes also from 1 to 10, with 1 meaning the lowest satiety and 10 meaning the highest one. | Up to three months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |