Clinical trial NCT03512665: Evaluation of the Impact of a Nutritional Supplement Made of Vegetable Oils in People at Risk of Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Pre-diabetes
cardiovascular risk
lipids
insulin resistance
obesity
overweight
Lead sponsor: University of Los Andes, Columbia
Sponsor class: OTHER
Collaborators: name: Team Foods Colombia S.A.
First posted: 2018-05-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Homeostasis Model Assessment - Insulin Resistance (HOMA-IR)
timeFrame: Measured at baseline and at week 8.
Secondary outcomes:
measure: Glycated hemoglobin A1c (HbA1c)
timeFrame: Measured at baseline and at week 8.
measure: Body-mass index
timeFrame: Assessed at baseline and at week 8
measure: Percent body fat.
timeFrame: Assessed at baseline and at week 8
measure: Percent abdominal fat
timeFrame: Assessed at baseline and at week 8.
measure: Lean body mass.
timeFrame: Assessed at baseline and at week 8.
measure: Waist circumference.
timeFrame: Assessed at baseline and at week 8.
measure: High-sensitivity C-reactive protein (hsCRP)
timeFrame: Measured at baseline and at week 8.
measure: Pigment epithelium-derived factor (PEDF).
timeFrame: Measured at baseline and at week 8.
measure: Change in plasma adiponectin
timeFrame: Measured at baseline and at week 8
measure: Change in plasma FGF-21
timeFrame: Measured at baseline and at week 8.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: University Of Los Andes Columbia
state: Cundinamarca
Study officials:
affiliation: University of Los Andes, Columbia
name: Carlos O Mendivil, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.