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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Dietary supplement: fortified canola oil with vitamins A and D and γ-oryzanol; Dietary supplement: Active comparator; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tirang R. Neyestani, PhD; Phone Number: 982122376471; Email: neytr@yahoo.com
• Study Contact Backup: Name: Bahareh Nikooyeh, PhD; Phone Number: 982122376471; Email: nikooyeh11024@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • 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
    • Contact: Tirang R. Neyestani, PhD; Phone Number: 982122376471; Email: neytr@yahoo.com
    • Contact: Bahareh Nikooyeh, PhD; Phone Number: 982122376471; Email: nikooyeh11024@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum glucose (mg/dL)	Fasting serum glucose level	8 weeks
serum HbA1c (mg/dL)	Fasting serum HbA1c level	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight (Kg)	Subject's weight wearing light clothing	8 weeks
Body Mass Index (Kg/m2)	weight (kg) divided by the square of height (m)	8 weeks
Waist circumference (cm)	the measurement at the midpoint between the lowest rib and the iliac crest	8 weeks
25-hydroxyvitamin D (nmol/L)	Fasting serum 25-hydroxyvitamin D level	8 weeks
serum triglyceride (mg/dL)	Fasting serum triglyceride level	8 weeks
serum total cholesterol (mg/dL)	Fasting serum total cholesterol level	8 weeks
serum LDL (mg/dL)	Fasting serum low density lipoprotein level	8 weeks
serum HDL (mg/dL)	Fasting serum high density lipoprotein level	8 weeks
serum insulin (pg/mL)	Fasting serum insulin level	8 weeks
serum BUN (mg/dL)	Fasting serum BUN level	8 weeks
serum creatinine (mg/dL)	Fasting serum creatinine level	8 weeks
serum leptin (pg/mL)	Fasting serum leptin level	8 weeks
serum grelin (pg/mL)	Fasting serum grelin level	8 weeks
serum hsCRP (pg/mL)	Fasting serum high sensitivity c-reactive protein level	8 weeks
serum IL-6 (pg/mL)	Fasting serum Interleukin-6 level	8 weeks
serum IL-1β (pg/mL)	Fasting serum Interleukin-1β level	8 weeks
serum INF-γ (pg/mL)	Fasting serum INF-γ level	8 weeks
salivary sIg-A (pg/mL)	Fasting Salivary Secretory Immunoglobulin A	8 weeks
ox-LDL (mg/dL)	Fasting oxidized low density lipoprotein level	8 weeks
MDA (mg/dL)	Fasting serum malondialdehyde level	8 weeks
TAC (mg/dL)	Fasting serum total antioxidant capacity level	8 weeks

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute
• Investigators: Study Chair: Tirang R. Neyestani, PhD, NationalNFTI, SBMU, Tehran, Iran

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: February 27, 2022
• First Submitted That Met QC Criteria: February 27, 2022
• First Posted (ACTUAL): March 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: vitamin D; vitamin A; fortified oil; γ-oryzanol
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Vitamin A
• Other Study ID Numbers: 25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No