Diabetes
Conditions
Keywords
vitamin A, vitamin D, γ-oryzanol, fortified oil
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTfortified canola oil with vitamins A and D and γ-oryzanol
30 g fortified canola oil with vitamins A and D and γ-oryzanol
DIETARY_SUPPLEMENTActive comparator
30 g fortified canola oil with vitamins A and D
DIETARY_SUPPLEMENTPlacebo
30 g fortified sunflower oil with vitamins A and D
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetic patients with fasting blood sugar above 100 mg/dL or hemoglobin A1c above 6% in the last test 2. Age between 20 to 65 years 3. No use of insulin
Exclusion criteria
1. Changing usual medicine intake or making any changes in diet and lifestyle that could alter the effectiveness of the intervention 2. Not using the fortified oil for three consecutive days or not using the fortified oil for more than ten days throughout the intervention period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum glucose (mg/dL) | 8 weeks | Fasting serum glucose level |
| serum HbA1c (mg/dL) | 8 weeks | Fasting serum HbA1c level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference (cm) | 8 weeks | the measurement at the midpoint between the lowest rib and the iliac crest |
| 25-hydroxyvitamin D (nmol/L) | 8 weeks | Fasting serum 25-hydroxyvitamin D level |
| serum triglyceride (mg/dL) | 8 weeks | Fasting serum triglyceride level |
| serum total cholesterol (mg/dL) | 8 weeks | Fasting serum total cholesterol level |
| serum LDL (mg/dL) | 8 weeks | Fasting serum low density lipoprotein level |
| serum HDL (mg/dL) | 8 weeks | Fasting serum high density lipoprotein level |
| serum insulin (pg/mL) | 8 weeks | Fasting serum insulin level |
| serum BUN (mg/dL) | 8 weeks | Fasting serum BUN level |
| serum creatinine (mg/dL) | 8 weeks | Fasting serum creatinine level |
| Weight (Kg) | 8 weeks | Subject's weight wearing light clothing |
| serum grelin (pg/mL) | 8 weeks | Fasting serum grelin level |
| serum hsCRP (pg/mL) | 8 weeks | Fasting serum high sensitivity c-reactive protein level |
| serum IL-6 (pg/mL) | 8 weeks | Fasting serum Interleukin-6 level |
| serum IL-1β (pg/mL) | 8 weeks | Fasting serum Interleukin-1β level |
| serum INF-γ (pg/mL) | 8 weeks | Fasting serum INF-γ level |
| salivary sIg-A (pg/mL) | 8 weeks | Fasting Salivary Secretory Immunoglobulin A |
| ox-LDL (mg/dL) | 8 weeks | Fasting oxidized low density lipoprotein level |
| MDA (mg/dL) | 8 weeks | Fasting serum malondialdehyde level |
| TAC (mg/dL) | 8 weeks | Fasting serum total antioxidant capacity level |
| serum leptin (pg/mL) | 8 weeks | Fasting serum leptin level |
| Body Mass Index (Kg/m2) | 8 weeks | weight (kg) divided by the square of height (m) |
Countries
Iran
Contacts
Primary ContactTirang R. Neyestani, PhD
Backup ContactBahareh Nikooyeh, PhD
Outcome results
None listed