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| Name | Class |
|---|---|
| Team Foods Colombia S.A. | INDUSTRY |
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Metabolic and cardiovascular diseases are the first cause of morbidity and mortality throughout the world, including Latin America and Colombia. Asymptomatic elevations of blood glucose, insufficient response to normal insulin concentrations (called insulin resistance), overweight and obesity can cause severe damage to body organs, leading to complications and even death. Worryingly, the prevalence of prediabetes is on the rise and efforts in public health policies made to contain this epidemic have had a very limited impact. This has prompted an intense search for non-pharmacological interventions. One of the most promising areas is research on "nutraceuticals", foods capable of positively impacting risk factors. However, there are insufficient nutritional or supplementary alternatives to favorably impact carbohydrate metabolism and cardiovascular risk factors in individuals at risk of diabetes. This project will evaluate the effects of the administration of a dietary supplement composed of vegetable oils. The fat composition of these oils is likely to impact positively on the metabolic profile of subjects at risk of diabetes and cardiovascular conditions.
Chronic non-communicable diseases (NCDs) account for 63% of deaths worldwide, of which 80% occur in low- and middle-income countries In Colombia, 71% of all deaths are related to NCDs . This pandemic can be prevented by controlling the risk factors, seeking to create interventions that impact more than one risk factor at a time, including body weight, blood glucose levels, blood pressure, cardiorespiratory fitness and other relatively minor risk factors.
On the other hand, diabetes mellitus is a major cause of morbidity and mortality worldwide . In its natural history, diabetes is preceded by factors that confer risk of diabetes and for a group of disorders known as "prediabetes" term comprising intolerance carbohydrates and impaired fasting glycaemia . Although people at risk of diabetes or prediabetes are often asymptomatic; lesions develop in micro and macrovascular beds and result in long-term kidney dysfunction, retinal damage and affectation of peripheral nerves and arteries. Vascular damage leads to an increased risk of retinopathy renal insufficiency , painful or autonomic neuropathy and atherosclerotic cardiovascular threatening diseases such as acute myocardial infarction.
The above situation has prompted an intense search for non-pharmacological interventions to intervene in patients at risk of diabetes and prevent negative consequences on the body in the short, medium and long term. One of the most promising areas of research is the nutraceuticals field. Colombian Team Foods S.A has developed a supplement of vegetable oils, that for their composition could have the ability to improve pathophysiological phenomena associated with the development of diabetes and its complications.
The main objective of this trial is to assess the impact of the consumption of a vegetable oils-based designed jointly by Team Foods and university of los Andes, on several indicators metabolic health in people at risk of diabetes. The specific objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full dose supplement group | Experimental | Patients assigned to this group will receive a daily dose of 7 mL of the study supplement (a mixture of pine, macadamia and pomegranate oils). The appearance and organoleptic properties will be similar to those of the interventions in the other two groups |
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| Low dose Supplement group | Experimental | Patients assigned to this group will receive a daily dose of 7 mL of a mixture containing 50% study supplement and 50% sunflower oil. The appearance and organoleptic properties will be similar to those of the interventions in the other two group |
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| Control Oil Group | Other | Patients assigned to this group will receive a daily 7 mL dose of an oil (sunflower oil) with appearance and organoleptic properties similar to those of the supplement provided in the intervention groups |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full dose supplement | Dietary Supplement | A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils. |
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| Measure | Description | Time Frame |
|---|---|---|
| Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) | Change in the HOMA-IR index at week 8, relative to baseline. HOMA-IR is calculated as the product of the fasting glycemia in mmol/L and fasting insulinemia in microunits/mL, divided by the constant 22.5. | Measured at baseline and at week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin A1c (HbA1c) | Change in the values of HbA1c at week 8, relative to baseline | Measured at baseline and at week 8. |
| Body-mass index | Change in the patients' BMI at week 8, relative to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos O Mendivil, MD. PhD | University of Los Andes, Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Los Andes Columbia | Bogotá | Cundinamarca | 111711 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31691133 | Derived | Pelaez-Jaramillo MJ, Valencia-Enciso N, Cardenas-Mojica AA, Gaete PV, Scher-Nemirovsky EA, Gomez-Arango LF, Colmenares-Araque D, Castro-Lopez CA, Betancourt-Villamizar E, Jaimes-Madrigal J, Alvarez CA, Jimenez-Mora MA, Quiroga-Padilla PJ, Puerto-Baracaldo DK, Mendivil CO. Impact of a Formulation Containing Unusual Polyunsaturated Fatty Acids, Trace Elements, Polyphenols and Plant Sterols on Insulin Resistance and Associated Disturbances. Diabetes Ther. 2020 Jan;11(1):229-245. doi: 10.1007/s13300-019-00721-z. Epub 2019 Nov 5. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Low dose Supplement | Dietary Supplement | A 7 mL vial composed of a mixture containing 50% study supplement (Pine, macadamia and pomegranate oils) and 50% sunflower oil. |
|
| Control Oil | Other | A 7ml vial composed of sunflower oil with appearance and organoleptic properties similar to those of the supplement provided in the intervention groups. |
|
| Assessed at baseline and at week 8 |
| Percent body fat. | Change in impedanciometry-estimated percent body fat at week 8, relative to baseline | Assessed at baseline and at week 8 |
| Percent abdominal fat | Change in impedanciometry-estimated percent abdominal fat at week 8, relative to baseline. | Assessed at baseline and at week 8. |
| Lean body mass. | Change in impedanciometry-estimated lean body mass. | Assessed at baseline and at week 8. |
| Waist circumference. | Change in waist circumference | Assessed at baseline and at week 8. |
| High-sensitivity C-reactive protein (hsCRP) | Change in plasma hsCRP. | Measured at baseline and at week 8. |
| Pigment epithelium-derived factor (PEDF). | Change in plasma levels of PEDF, a biomarker of insulin resistance. | Measured at baseline and at week 8. |
| Change in plasma adiponectin | Change in plasma levels of total adiponectin. | Measured at baseline and at week 8 |
| Change in plasma FGF-21 | Change in plasma levels of Fibroblast growth factor 21 (FGF-21). | Measured at baseline and at week 8. |
| D006943 | Hyperglycemia |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |