MedTrace Logo

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

NCT03512665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-10-11

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Full dose supplement

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

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.

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.

Sponsors & Collaborators

  • Team Foods Colombia S.A.

    collaborator INDUSTRY

  • University of Los Andes, Columbia

    lead OTHER

Principal Investigators

  • Carlos O Mendivil, MD. PhD · University of Los Andes, Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-07
Primary Completion
2018-06-16
Completion
2018-10-02

Countries

  • Colombia

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512665 on ClinicalTrials.gov