NCT03512665

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

Completed NA Last updated 11 October 2018

What this trial tests

NA trial testing Full dose supplement in Insulin Resistance in 25 participants. Completed in 2 October 2018.

Timeline

7 April 2018

Primary endpoint
16 June 2018

2 October 2018

Quick facts

Lead sponsor	University of Los Andes, Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	25
Start date	7 April 2018
Primary completion	16 June 2018
Estimated completion	2 October 2018
Sites	1 location across Colombia

Drugs / interventions tested

• Full dose supplement
• Low dose Supplement
• Control Oil

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

University of Los Andes, Columbia

Who can join

18 and older, any sex, with Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of a Formulation Containing Unusual Polyunsaturated Fatty Acids, Trace Elements, Polyphenols and Plant Sterols on Insulin Resistance and Associated Disturbances.
   Peláez-Jaramillo MJ, Valencia-Enciso N, Cárdenas-Mojica AA, Gaete PV, et al · · 2020 · cited 3× · PMID 31691133 · DOI 10.1007/s13300-019-00721-z