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

NCT03512665 | Completed

• 1 other identifier: TFC-111-2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

Pre-diabetes; cardiovascular risk; lipids; insulin resistance; obesity; overweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Glycated hemoglobin A1c (HbA1c)

  Measured at baseline and at week 8.

• Body-mass index

  Assessed at baseline and at week 8

• Percent body fat.

  Assessed at baseline and at week 8

• Percent abdominal fat

  Assessed at baseline and at week 8.

• Lean body mass.

  Assessed at baseline and at week 8.

Study Arms (3)

Full dose supplement group

EXPERIMENTAL

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

Dietary Supplement: Full dose supplement

Low dose Supplement group

EXPERIMENTAL

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

Dietary Supplement: Low dose Supplement

Control Oil Group

OTHER

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

Other: Control Oil

Interventions

Full dose supplement DIETARY_SUPPLEMENT

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

Full dose supplement group

Low dose Supplement DIETARY_SUPPLEMENT

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

Low dose Supplement group

Control Oil OTHER

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

Control Oil Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Los Andes, Columbia: lead
• Team Foods Colombia S.A.: collaborator

Study Sites (1)

University Of Los Andes Columbia

Bogotá, Cundinamarca, 111711, Colombia

Location

Related Publications (1)

• 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.

  PMID: 31691133 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Obesity; Overweight

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos O Mendivil, MD. PhD

  University of Los Andes, Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 1, 2018
• Study Start: April 7, 2018
• Primary Completion: June 16, 2018
• Study Completion: October 2, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CO (1)