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

• Sponsor: National Nutrition and Food Technology Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05271045
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 12.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol; Dietary Supplement: Active comparator; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	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
Active Comparator: fortified canola oil with vitamins A and D daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g)	Dietary Supplement: Active comparator; 30 g fortified canola oil with vitamins A and D
Placebo Comparator: fortified sunflower oil with vitamins A and D daily intake of fortified sunflower oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g)	Dietary Supplement: Placebo; 30 g fortified sunflower oil with vitamins A and D

Outcome Measures

Primary Outcome Measures

1. serum glucose (mg/dL) [8 weeks]

   Fasting serum glucose level

2. serum HbA1c (mg/dL) [8 weeks]

   Fasting serum HbA1c level

Secondary Outcome Measures

1. Weight (Kg) [8 weeks]

   Subject's weight wearing light clothing

2. Body Mass Index (Kg/m2) [8 weeks]

   weight (kg) divided by the square of height (m)

3. Waist circumference (cm) [8 weeks]

   the measurement at the midpoint between the lowest rib and the iliac crest

4. 25-hydroxyvitamin D (nmol/L) [8 weeks]

   Fasting serum 25-hydroxyvitamin D level

5. serum triglyceride (mg/dL) [8 weeks]

   Fasting serum triglyceride level

6. serum total cholesterol (mg/dL) [8 weeks]

   Fasting serum total cholesterol level

7. serum LDL (mg/dL) [8 weeks]

   Fasting serum low density lipoprotein level

8. serum HDL (mg/dL) [8 weeks]

   Fasting serum high density lipoprotein level

9. serum insulin (pg/mL) [8 weeks]

   Fasting serum insulin level

10. serum BUN (mg/dL) [8 weeks]

    Fasting serum BUN level

11. serum creatinine (mg/dL) [8 weeks]

    Fasting serum creatinine level

12. serum leptin (pg/mL) [8 weeks]

    Fasting serum leptin level

13. serum grelin (pg/mL) [8 weeks]

    Fasting serum grelin level

14. serum hsCRP (pg/mL) [8 weeks]

    Fasting serum high sensitivity c-reactive protein level

15. serum IL-6 (pg/mL) [8 weeks]

    Fasting serum Interleukin-6 level

16. serum IL-1β (pg/mL) [8 weeks]

    Fasting serum Interleukin-1β level

17. serum INF-γ (pg/mL) [8 weeks]

    Fasting serum INF-γ level

18. salivary sIg-A (pg/mL) [8 weeks]

    Fasting Salivary Secretory Immunoglobulin A

19. ox-LDL (mg/dL) [8 weeks]

    Fasting oxidized low density lipoprotein level

20. MDA (mg/dL) [8 weeks]

    Fasting serum malondialdehyde level

21. TAC (mg/dL) [8 weeks]

    Fasting serum total antioxidant capacity level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• National Nutrition and Food Technology Institute

Investigators

• Study Chair: Tirang R. Neyestani, PhD, NationalNFTI, SBMU, Tehran, Iran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tirang R. Neyestani, Ph.D., Prof., National Nutrition and Food Technology Institute
• ClinicalTrials.gov Identifier: NCT05271045
• Other Study ID Numbers: 25
• First Posted: Mar 8, 2022
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tirang R. Neyestani, Ph.D., Prof., National Nutrition and Food Technology Institute: vitamin A; vitamin D; γ-oryzanol; fortified oil
• Additional relevant MeSH terms: Diabetes Mellitus; Vitamin D; Vitamin A

Study Results

No Results Posted as of Mar 8, 2022