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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fortified canola oil with vitamins A and D and γ-oryzanol | Experimental | daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g & 2130 ppm γ-oryzanol/30g) |
|
| fortified canola oil with vitamins A and D | Active Comparator | daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g) |
|
| fortified sunflower oil with vitamins A and D | Placebo Comparator | daily intake of fortified sunflower oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fortified canola oil with vitamins A and D and γ-oryzanol | Dietary Supplement | 30 g fortified canola oil with vitamins A and D and γ-oryzanol |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum glucose (mg/dL) | Fasting serum glucose level | 8 weeks |
| serum HbA1c (mg/dL) | Fasting serum HbA1c level | 8 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tirang R. Neyestani, PhD | Contact | 982122376471 | neytr@yahoo.com | |
| Bahareh Nikooyeh, PhD | Contact | 982122376471 | nikooyeh11024@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, PhD | NationalNFTI, SBMU, Tehran, Iran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran | Recruiting | Tehran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37971692 | Derived | Nikooyeh B, Zargaraan A, Ebrahimof S, Kalayi A, Zahedirad M, Yazdani H, Rismanchi M, Karami T, Khazraei M, Jafarpour A, Neyestani TR. Added gamma-oryzanol boosted anti-inflammatory effects of canola oil in adult subjects with type 2 diabetes: a randomized controlled clinical trial. Eur J Nutr. 2024 Mar;63(2):425-433. doi: 10.1007/s00394-023-03275-w. Epub 2023 Nov 16. | |
| 37817285 |
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| Active comparator | Dietary Supplement | 30 g fortified canola oil with vitamins A and D |
|
| Placebo | Dietary Supplement | 30 g fortified sunflower oil with vitamins A and D |
|
| 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 |
| Iran |
|
| Nikooyeh B, Zargaraan A, Ebrahimof S, Kalayi A, Zahedirad M, Yazdani H, Rismanchi M, Karami T, Khazraei M, Jafarpour A, Neyestani TR. Daily consumption of gamma-oryzanol-fortified canola oil, compared with unfortified canola and sunflower oils, resulted in a better improvement of certain cardiometabolic biomarkers of adult subjects with type 2 diabetes: a randomized controlled clinical trial. Eur J Med Res. 2023 Oct 10;28(1):416. doi: 10.1186/s40001-023-01409-8. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C007792 | Fumigant 93 |
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