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

National Nutrition and Food Technology Institute

Status: Unknown

Conditions: Diabetes

Treatments: Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol; Dietary Supplement: Active comparator; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05271045

25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

fortified canola oil with vitamins A and D and γ-oryzanol

Experimental group

Description:

daily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g \& 2130 ppm γ-oryzanol/30g)

Treatment:

Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol

fortified canola oil with vitamins A and D

Active Comparator group

Description:

daily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g)

Treatment:

Dietary Supplement: Active comparator

fortified sunflower oil with vitamins A and D

Placebo Comparator group

Description:

daily intake of fortified sunflower oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g)

Treatment:

Dietary Supplement: Placebo