NCT05271045

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	fortified canola oil with vitamins A and D and γ-oryzanol	30 g fortified canola oil with vitamins A and D and γ-oryzanol
DIETARY_SUPPLEMENT	Active comparator	30 g fortified canola oil with vitamins A and D
DIETARY_SUPPLEMENT	Placebo	30 g fortified sunflower oil with vitamins A and D

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-04-01
• Completion: 2022-07-01
• First posted: 2022-03-08
• Last updated: 2022-03-08

Locations

1 site across 1 country: Iran