An interventional study of fortified canola oil with vitamins A and D and γ-oryzanol and Active comparator in Diabetes, sponsored by National Nutrition and Food Technology Institute. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by National Nutrition and Food Technology Institute · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →National Nutrition and Food Technology Institute is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
daily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g)
Dietary Supplement: Active comparator
daily intake of fortified sunflower oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g)
Dietary Supplement: Placebo
30 g fortified canola oil with vitamins A and D and γ-oryzanol
30 g fortified canola oil with vitamins A and D
30 g fortified sunflower oil with vitamins A and D
serum glucose (mg/dL)
Fasting serum glucose level
Time frame: 8 weeks
serum HbA1c (mg/dL)
Fasting serum HbA1c level
Time frame: 8 weeks
Weight (Kg)
Subject's weight wearing light clothing
Time frame: 8 weeks
Body Mass Index (Kg/m2)
weight (kg) divided by the square of height (m)
Time frame: 8 weeks
Waist circumference (cm)
the measurement at the midpoint between the lowest rib and the iliac crest
Time frame: 8 weeks
25-hydroxyvitamin D (nmol/L)
Fasting serum 25-hydroxyvitamin D level
Time frame: 8 weeks
serum triglyceride (mg/dL)
Fasting serum triglyceride level
Time frame: 8 weeks
serum total cholesterol (mg/dL)
Fasting serum total cholesterol level
Time frame: 8 weeks
serum LDL (mg/dL)
Fasting serum low density lipoprotein level
Time frame: 8 weeks
serum HDL (mg/dL)
Fasting serum high density lipoprotein level
Time frame: 8 weeks
serum insulin (pg/mL)
Fasting serum insulin level
Time frame: 8 weeks
serum BUN (mg/dL)
Fasting serum BUN level
Time frame: 8 weeks
serum creatinine (mg/dL)
Fasting serum creatinine level
Time frame: 8 weeks
serum leptin (pg/mL)
Fasting serum leptin level
Time frame: 8 weeks
serum grelin (pg/mL)
Fasting serum grelin level
Time frame: 8 weeks
serum hsCRP (pg/mL)
Fasting serum high sensitivity c-reactive protein level
Time frame: 8 weeks
serum IL-6 (pg/mL)
Fasting serum Interleukin-6 level
Time frame: 8 weeks
serum IL-1β (pg/mL)
Fasting serum Interleukin-1β level
Time frame: 8 weeks
serum INF-γ (pg/mL)
Fasting serum INF-γ level
Time frame: 8 weeks
salivary sIg-A (pg/mL)
Fasting Salivary Secretory Immunoglobulin A
Time frame: 8 weeks
ox-LDL (mg/dL)
Fasting oxidized low density lipoprotein level
Time frame: 8 weeks
MDA (mg/dL)
Fasting serum malondialdehyde level
Time frame: 8 weeks
TAC (mg/dL)
Fasting serum total antioxidant capacity level
Time frame: 8 weeks
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Nutrition and Food Technology Institute