Clinical trial NCT05271045: Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: vitamin A
vitamin D
γ-oryzanol
fortified oil
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum glucose (mg/dL)
timeFrame: 8 weeks
measure: serum HbA1c (mg/dL)
timeFrame: 8 weeks
Secondary outcomes:
measure: Weight (Kg)
timeFrame: 8 weeks
measure: Body Mass Index (Kg/m2)
timeFrame: 8 weeks
measure: Waist circumference (cm)
timeFrame: 8 weeks
measure: 25-hydroxyvitamin D (nmol/L)
timeFrame: 8 weeks
measure: serum triglyceride (mg/dL)
timeFrame: 8 weeks
measure: serum total cholesterol (mg/dL)
timeFrame: 8 weeks
measure: serum LDL (mg/dL)
timeFrame: 8 weeks
measure: serum HDL (mg/dL)
timeFrame: 8 weeks
measure: serum insulin (pg/mL)
timeFrame: 8 weeks
measure: serum BUN (mg/dL)
timeFrame: 8 weeks
measure: serum creatinine (mg/dL)
timeFrame: 8 weeks
measure: serum leptin (pg/mL)
timeFrame: 8 weeks
measure: serum grelin (pg/mL)
timeFrame: 8 weeks
measure: serum hsCRP (pg/mL)
timeFrame: 8 weeks
measure: serum IL-6 (pg/mL)
timeFrame: 8 weeks
measure: serum IL-1β (pg/mL)
timeFrame: 8 weeks
measure: serum INF-γ (pg/mL)
timeFrame: 8 weeks
measure: salivary sIg-A (pg/mL)
timeFrame: 8 weeks
measure: ox-LDL (mg/dL)
timeFrame: 8 weeks
measure: MDA (mg/dL)
timeFrame: 8 weeks
measure: TAC (mg/dL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: 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
Study officials:
affiliation: NationalNFTI, SBMU, Tehran, Iran
name: Tirang R. Neyestani, PhD
role: STUDY_CHAIR
References: