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

NCT ID: NCT03512665

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-07
• Study Completion Date: 2018-10-02

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Full dose supplement group

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

Group Type: EXPERIMENTAL

Full dose supplement

Intervention Type: DIETARY_SUPPLEMENT

A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils.

Low dose Supplement group

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

Group Type: EXPERIMENTAL

Low dose Supplement

Intervention Type: 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 Group

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

Group Type: OTHER

Control Oil

Intervention Type: OTHER

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

Interventions

Full dose supplement

A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils.

Intervention Type: DIETARY_SUPPLEMENT

Low dose Supplement

A 7 mL vial composed of a mixture containing 50% study supplement (Pine, macadamia and pomegranate oils) and 50% sunflower oil.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Team Foods Colombia S.A.

INDUSTRY

Sponsor Role: collaborator

University of Los Andes, Columbia

OTHER

Sponsor Role: lead

Responsible Party

Carlos O Mendivil

Associate Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos O Mendivil, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Los Andes, Columbia

Locations

University Of Los Andes Columbia

Bogotá, Cundinamarca, Colombia

Countries

Colombia

References

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.

Reference Type: DERIVED

PMID: 31691133 (View on PubMed)

Other Identifiers

TFC-111-2017

Identifier Type: -

Identifier Source: org_study_id