- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03512665
Evaluation of the Impact of a Nutritional Supplement Made of Vegetable Oils in People at Risk of Diabetes
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cundinamarca
-
Bogotá, Cundinamarca, Colombia, 111711
- University Of Los Andes Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils.
|
Experimental: 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
|
A 7 mL vial composed of a mixture containing 50% study supplement (Pine, macadamia and pomegranate oils) and 50% sunflower oil.
|
Other: 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
|
A 7ml vial composed of sunflower oil with appearance and organoleptic properties similar to those of the supplement provided in the intervention groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Homeostasis Model Assessment - Insulin Resistance (HOMA-IR)
Time Frame: Measured at baseline and at week 8.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycated hemoglobin A1c (HbA1c)
Time Frame: Measured at baseline and at week 8.
|
Change in the values of HbA1c at week 8, relative to baseline
|
Measured at baseline and at week 8.
|
Body-mass index
Time Frame: Assessed at baseline and at week 8
|
Change in the patients' BMI at week 8, relative to baseline
|
Assessed at baseline and at week 8
|
Percent body fat.
Time Frame: Assessed at baseline and at week 8
|
Change in impedanciometry-estimated percent body fat at week 8, relative to baseline
|
Assessed at baseline and at week 8
|
Percent abdominal fat
Time Frame: Assessed at baseline and at week 8.
|
Change in impedanciometry-estimated percent abdominal fat at week 8, relative to baseline.
|
Assessed at baseline and at week 8.
|
Lean body mass.
Time Frame: Assessed at baseline and at week 8.
|
Change in impedanciometry-estimated lean body mass.
|
Assessed at baseline and at week 8.
|
Waist circumference.
Time Frame: Assessed at baseline and at week 8.
|
Change in waist circumference
|
Assessed at baseline and at week 8.
|
High-sensitivity C-reactive protein (hsCRP)
Time Frame: Measured at baseline and at week 8.
|
Change in plasma hsCRP.
|
Measured at baseline and at week 8.
|
Pigment epithelium-derived factor (PEDF).
Time Frame: Measured at baseline and at week 8.
|
Change in plasma levels of PEDF, a biomarker of insulin resistance.
|
Measured at baseline and at week 8.
|
Change in plasma adiponectin
Time Frame: Measured at baseline and at week 8
|
Change in plasma levels of total adiponectin.
|
Measured at baseline and at week 8
|
Change in plasma FGF-21
Time Frame: Measured at baseline and at week 8.
|
Change in plasma levels of Fibroblast growth factor 21 (FGF-21).
|
Measured at baseline and at week 8.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carlos O Mendivil, MD. PhD, University of Los Andes, Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TFC-111-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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