Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of daily intake of fortified canola oil with vitamins A and D and γ-oryzanol on anthropometric, inflammatory, immunity, appetite and metabolic indicators of adults with type 2 diabetes compared to canola and sunflower oil without γoryzanol.

Detailed Description
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Ninety confirmed type 2 diabetes patients aged 20-65 years old will be selected. Participants who change their usual medicine intake or make any changes in their diet and lifestyle that could alter the effectiveness of the intervention as well as those who do not use the fortified oil for three consecutive days or do not use the fortified oil for more than ten days throughout the intervention will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified canola oil with vitamins A and D and γ-oryzanol , 2. fortified canola oil with vitamins A and D, 3. fortified sunflower oil with vitamins A and D. Each participant will consume 30 g of oil every day for 2 months. At the first and last visits, dietary and laboratory assessments will be performed for all subjects. The primary outcomes are the improvement of anthropometric, inflammatory, immunity, appetite, glycemic, and lipidemic markers of adults with type 2 diabetes.

Official Title
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Formulation of Canola Oil With Vitamins A and D and γ-oryzanol and Evaluation of the Efficacy of Its Consumption Compared to Canola and Sunflower Oil Without γoryzanol in Adults With Type 2 Diabetes: a Randomized Controlled Clinical Trial

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol
* Dietary Supplement: Active comparator
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients with fasting blood sugar above 100 mg/dL or hemoglobin A1c above 6% in the last test Age between 20 to 65 years No use of insulin Exclusion Criteria: Changing usual medicine intake or making any changes in diet and lifestyle that could alter the effectiveness of the intervention Not using the fortified oil for three consecutive days or not using the fortified oil for more than ten days throughout the intervention period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fortified canola oil with vitamins A and D and γ-oryzanol<br>daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g & 2130 ppm γ-oryzanol/30g) | Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol<br>* 30 g fortified canola oil with vitamins A and D and γ-oryzanol<br>|
| Active Comparator: fortified canola oil with vitamins A and D<br>daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g) | Dietary Supplement: Active comparator<br>* 30 g fortified canola oil with vitamins A and D<br>|
| Placebo Comparator: fortified sunflower oil with vitamins A and D<br>daily intake of fortified sunflower oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g) | Dietary Supplement: Placebo<br>* 30 g fortified sunflower oil with vitamins A and D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum glucose (mg/dL) | Fasting serum glucose level | 8 weeks | 
| serum HbA1c (mg/dL) | Fasting serum HbA1c level | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (Kg) | Subject's weight wearing light clothing | 8 weeks | 
| Body Mass Index (Kg/m2) | weight (kg) divided by the square of height (m) | 8 weeks | 
| Waist circumference (cm) | the measurement at the midpoint between the lowest rib and the iliac crest | 8 weeks | 
| 25-hydroxyvitamin D (nmol/L) | Fasting serum 25-hydroxyvitamin D level | 8 weeks | 
| serum triglyceride (mg/dL) | Fasting serum triglyceride level | 8 weeks | 
| serum total cholesterol (mg/dL) | Fasting serum total cholesterol level | 8 weeks | 
| serum LDL (mg/dL) | Fasting serum low density lipoprotein level | 8 weeks | 
| serum HDL (mg/dL) | Fasting serum high density lipoprotein level | 8 weeks | 
| serum insulin (pg/mL) | Fasting serum insulin level | 8 weeks | 
| serum BUN (mg/dL) | Fasting serum BUN level | 8 weeks | 
| serum creatinine (mg/dL) | Fasting serum creatinine level | 8 weeks | 
| serum leptin (pg/mL) | Fasting serum leptin level | 8 weeks | 
| serum grelin (pg/mL) | Fasting serum grelin level | 8 weeks | 
| serum hsCRP (pg/mL) | Fasting serum high sensitivity c-reactive protein level | 8 weeks | 
| serum IL-6 (pg/mL) | Fasting serum Interleukin-6 level | 8 weeks | 
| serum IL-1β (pg/mL) | Fasting serum Interleukin-1β level | 8 weeks | 
| serum INF-γ (pg/mL) | Fasting serum INF-γ level | 8 weeks | 
| salivary sIg-A (pg/mL) | Fasting Salivary Secretory Immunoglobulin A | 8 weeks | 
| ox-LDL (mg/dL) | Fasting oxidized low density lipoprotein level | 8 weeks | 
| MDA (mg/dL) | Fasting serum malondialdehyde level | 8 weeks | 
| TAC (mg/dL) | Fasting serum total antioxidant capacity level | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin A, vitamin D, γ-oryzanol, fortified oil