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

Not Applicable

• Conditions: Diabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Active comparator; Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol

• Registration Number: NCT05271045
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Study Timeline

• Study Start: 2021-12-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-27
• Study First Submitted QC: 2022-02-27
• Last Update Submitted: 2022-02-27
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2022-04-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fortified sunflower oil with vitamins A and D	Placebo	daily intake of fortified sunflower oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g)
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 canola oil with vitamins A and D and γ-oryzanol	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 \& 2130 ppm γ-oryzanol/30g)

Primary Outcome Measures

Name	Time	Method
serum glucose (mg/dL)	8 weeks	Fasting serum glucose level
serum HbA1c (mg/dL)	8 weeks	Fasting serum HbA1c level

Secondary Outcome Measures

Name	Time	Method
serum INF-γ (pg/mL)	8 weeks	Fasting serum INF-γ level
serum triglyceride (mg/dL)	8 weeks	Fasting serum triglyceride level
ox-LDL (mg/dL)	8 weeks	Fasting oxidized low density lipoprotein level
serum leptin (pg/mL)	8 weeks	Fasting serum leptin 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
salivary sIg-A (pg/mL)	8 weeks	Fasting Salivary Secretory Immunoglobulin A
MDA (mg/dL)	8 weeks	Fasting serum malondialdehyde 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
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 total cholesterol (mg/dL)	8 weeks	Fasting serum total cholesterol level
serum LDL (mg/dL)	8 weeks	Fasting serum low density lipoprotein level
Body Mass Index (Kg/m2)	8 weeks	weight (kg) divided by the square of height (m)
serum IL-1β (pg/mL)	8 weeks	Fasting serum Interleukin-1β level
TAC (mg/dL)	8 weeks	Fasting serum total antioxidant capacity level
Weight (Kg)	8 weeks	Subject's weight wearing light clothing
serum creatinine (mg/dL)	8 weeks	Fasting serum creatinine level
serum grelin (pg/mL)	8 weeks	Fasting serum grelin level

Trial Locations

Locations (1)

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; 🇮🇷 Tehran, Iran, Islamic Republic of