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

Insulin Resistance Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512665
• Other study ID #: TFC-111-2017
• Status: Completed
• Phase: N/A
• Start date: April 7, 2018
• Est. completion date: October 2, 2018

Study information

• Verified date: October 2018
• Source: University of Los Andes, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2, 2018
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• Full dose supplement
A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils.
• Low dose Supplement
A 7 mL vial composed of a mixture containing 50% study supplement (Pine, macadamia and pomegranate oils) and 50% sunflower oil.

Other:
• Control Oil
A 7ml vial composed of sunflower oil with appearance and organoleptic properties similar to those of the supplement provided in the intervention groups.

Locations

Country	Name	City	State
Colombia	University Of Los Andes Columbia	Bogotá	Cundinamarca

Sponsors (2)

Lead Sponsor	Collaborator
University of Los Andes, Columbia	Team Foods Colombia S.A.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycated hemoglobin A1c (HbA1c)	Change in the values of HbA1c at week 8, relative to baseline	Measured at baseline and at week 8.
Secondary	Body-mass index	Change in the patients' BMI at week 8, relative to baseline	Assessed at baseline and at week 8
Secondary	Percent body fat.	Change in impedanciometry-estimated percent body fat at week 8, relative to baseline	Assessed at baseline and at week 8
Secondary	Percent abdominal fat	Change in impedanciometry-estimated percent abdominal fat at week 8, relative to baseline.	Assessed at baseline and at week 8.
Secondary	Lean body mass.	Change in impedanciometry-estimated lean body mass.	Assessed at baseline and at week 8.
Secondary	Waist circumference.	Change in waist circumference	Assessed at baseline and at week 8.
Secondary	High-sensitivity C-reactive protein (hsCRP)	Change in plasma hsCRP.	Measured at baseline and at week 8.
Secondary	Pigment epithelium-derived factor (PEDF).	Change in plasma levels of PEDF, a biomarker of insulin resistance.	Measured at baseline and at week 8.
Secondary	Change in plasma adiponectin	Change in plasma levels of total adiponectin.	Measured at baseline and at week 8
Secondary	Change in plasma FGF-21	Change in plasma levels of Fibroblast growth factor 21 (FGF-21).	Measured at baseline and at week 8.