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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271045
• Other study ID #: 25
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2022
• Source: National Nutrition and Food Technology Institute
• Contact: Tirang R. Neyestani, PhD
• Phone: 982122376471
• Email: neytr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Dietary Supplement:
• fortified canola oil with vitamins A and D and ?-oryzanol
30 g fortified canola oil with vitamins A and D and ?-oryzanol
• Active comparator
30 g fortified canola oil with vitamins A and D
• Placebo
30 g fortified sunflower oil with vitamins A and D

Locations

Country	Name	City	State
Iran, Islamic Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum glucose (mg/dL)	Fasting serum glucose level	8 weeks
Primary	serum HbA1c (mg/dL)	Fasting serum HbA1c level	8 weeks
Secondary	Weight (Kg)	Subject's weight wearing light clothing	8 weeks
Secondary	Body Mass Index (Kg/m2)	weight (kg) divided by the square of height (m)	8 weeks
Secondary	Waist circumference (cm)	the measurement at the midpoint between the lowest rib and the iliac crest	8 weeks
Secondary	25-hydroxyvitamin D (nmol/L)	Fasting serum 25-hydroxyvitamin D level	8 weeks
Secondary	serum triglyceride (mg/dL)	Fasting serum triglyceride level	8 weeks
Secondary	serum total cholesterol (mg/dL)	Fasting serum total cholesterol level	8 weeks
Secondary	serum LDL (mg/dL)	Fasting serum low density lipoprotein level	8 weeks
Secondary	serum HDL (mg/dL)	Fasting serum high density lipoprotein level	8 weeks
Secondary	serum insulin (pg/mL)	Fasting serum insulin level	8 weeks
Secondary	serum BUN (mg/dL)	Fasting serum BUN level	8 weeks
Secondary	serum creatinine (mg/dL)	Fasting serum creatinine level	8 weeks
Secondary	serum leptin (pg/mL)	Fasting serum leptin level	8 weeks
Secondary	serum grelin (pg/mL)	Fasting serum grelin level	8 weeks
Secondary	serum hsCRP (pg/mL)	Fasting serum high sensitivity c-reactive protein level	8 weeks
Secondary	serum IL-6 (pg/mL)	Fasting serum Interleukin-6 level	8 weeks
Secondary	serum IL-1ß (pg/mL)	Fasting serum Interleukin-1ß level	8 weeks
Secondary	serum INF-? (pg/mL)	Fasting serum INF-? level	8 weeks
Secondary	salivary sIg-A (pg/mL)	Fasting Salivary Secretory Immunoglobulin A	8 weeks
Secondary	ox-LDL (mg/dL)	Fasting oxidized low density lipoprotein level	8 weeks
Secondary	MDA (mg/dL)	Fasting serum malondialdehyde level	8 weeks
Secondary	TAC (mg/dL)	Fasting serum total antioxidant capacity level	8 weeks