Evaluation of the Impact of a Nutritional Supplement Made of Vegetable Oils in People at Risk of Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To enroll a sample of patients who are at risk of diabetes but have not receive drugs to control plasma glucose, cholesterol or triglycerides, and have not developed complications like kidney or eye dysfunction. To evaluate the effect of daily consumption of the study supplement on fasting blood glucose, the area under the glucose curve in an oral glucose tolerance test, and glycated hemoglobin (HbA1c-an indicator of blood glucose levels over the last 3 months). To evaluate the effect of the supplement on indexes and biomarkers of insulin resistance. To evaluate the effect of the supplement on other cardiovascular risk factors including lipid profile, blood pressure, body weight and body composition.

Official Title
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Impact of a Supplement of Vegetable Oils on Body Weight and Composition, Insulin Sensitivity and Other Cardiovascular Risk Factors in People at Risk of Developing Type 2 Diabetes Mellitus.

Conditions
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Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Full dose supplement
* Dietary Supplement: Low dose Supplement
* Other: Control Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older. Risk of type 2 diabetes (T2DM) given by BMI 25 kg/m2 or greater and / or Finnish Diabetes Risk Score(FinnRisc) greater than 12. Manifest desire to participate in the study, and provision of informed consent. Participants must continue their regular eating habits and physical activity. Exclusion Criteria: Current participation in a systematic weight loss program. Current use of medications that modify insulin sensitivity (except contraceptives in the case of women). Known hypersensitivity to any component of the supplement. Gastrointestinal problems that negatively affect the adherence to the study intervention. Known complications from diabetes or hypertension: Coronary heart disease, nephropathy, retinopathy, cerebrovascular disease, diabetic foot or painful neuropathy. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full dose supplement group<br>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 | Dietary Supplement: Full dose supplement<br>* A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils.<br>|
| Experimental: Low dose Supplement group<br>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 | Dietary Supplement: Low dose Supplement<br>* A 7 mL vial composed of a mixture containing 50% study supplement (Pine, macadamia and pomegranate oils) and 50% sunflower oil.<br>|
| Other: Control Oil Group<br>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 | Other: Control Oil<br>* A 7ml vial composed of sunflower oil with appearance and organoleptic properties similar to those of the supplement provided in the intervention groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-diabetes, cardiovascular risk, lipids, insulin resistance, obesity, overweight