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

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
fortified canola oil with vitamins A and D and γ-oryzanol
Active comparator
Placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring vitamin A, vitamin D, γ-oryzanol, fortified oil

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 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, IranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

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

fortified canola oil with vitamins A and D

fortified sunflower oil with vitamins A and D

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

serum glucose (mg/dL)
Fasting serum glucose level
serum HbA1c (mg/dL)
Fasting serum HbA1c level

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2022
Last Updated
February 27, 2022
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05271045
Brief Title
Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
vitamin A, vitamin D, γ-oryzanol, fortified oil

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fortified canola oil with vitamins A and D and γ-oryzanol
Arm Type
Experimental
Arm Description
daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g & 2130 ppm γ-oryzanol/30g)
Arm Title
fortified canola oil with vitamins A and D
Arm Type
Active Comparator
Arm Description
daily intake of fortified canola oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g)
Arm Title
fortified sunflower oil with vitamins A and D
Arm Type
Placebo Comparator
Arm Description
daily intake of fortified sunflower oil (385 IU vitamin D/ 30g & 154 IU vitamin A/30 g)
Intervention Type
Dietary Supplement
Intervention Name(s)
fortified canola oil with vitamins A and D and γ-oryzanol
Intervention Description
30 g fortified canola oil with vitamins A and D and γ-oryzanol
Intervention Type
Dietary Supplement
Intervention Name(s)
Active comparator
Intervention Description
30 g fortified canola oil with vitamins A and D
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
30 g fortified sunflower oil with vitamins A and D
Primary Outcome Measure Information:
Title
serum glucose (mg/dL)
Description
Fasting serum glucose level
Time Frame
8 weeks
Title
serum HbA1c (mg/dL)
Description
Fasting serum HbA1c level
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Weight (Kg)
Description
Subject's weight wearing light clothing
Time Frame
8 weeks
Title
Body Mass Index (Kg/m2)
Description
weight (kg) divided by the square of height (m)
Time Frame
8 weeks
Title
Waist circumference (cm)
Description
the measurement at the midpoint between the lowest rib and the iliac crest
Time Frame
8 weeks
Title
25-hydroxyvitamin D (nmol/L)
Description
Fasting serum 25-hydroxyvitamin D level
Time Frame
8 weeks
Title
serum triglyceride (mg/dL)
Description
Fasting serum triglyceride level
Time Frame
8 weeks
Title
serum total cholesterol (mg/dL)
Description
Fasting serum total cholesterol level
Time Frame
8 weeks
Title
serum LDL (mg/dL)
Description
Fasting serum low density lipoprotein level
Time Frame
8 weeks
Title
serum HDL (mg/dL)
Description
Fasting serum high density lipoprotein level
Time Frame
8 weeks
Title
serum insulin (pg/mL)
Description
Fasting serum insulin level
Time Frame
8 weeks
Title
serum BUN (mg/dL)
Description
Fasting serum BUN level
Time Frame
8 weeks
Title
serum creatinine (mg/dL)
Description
Fasting serum creatinine level
Time Frame
8 weeks
Title
serum leptin (pg/mL)
Description
Fasting serum leptin level
Time Frame
8 weeks
Title
serum grelin (pg/mL)
Description
Fasting serum grelin level
Time Frame
8 weeks
Title
serum hsCRP (pg/mL)
Description
Fasting serum high sensitivity c-reactive protein level
Time Frame
8 weeks
Title
serum IL-6 (pg/mL)
Description
Fasting serum Interleukin-6 level
Time Frame
8 weeks
Title
serum IL-1β (pg/mL)
Description
Fasting serum Interleukin-1β level
Time Frame
8 weeks
Title
serum INF-γ (pg/mL)
Description
Fasting serum INF-γ level
Time Frame
8 weeks
Title
salivary sIg-A (pg/mL)
Description
Fasting Salivary Secretory Immunoglobulin A
Time Frame
8 weeks
Title
ox-LDL (mg/dL)
Description
Fasting oxidized low density lipoprotein level
Time Frame
8 weeks
Title
MDA (mg/dL)
Description
Fasting serum malondialdehyde level
Time Frame
8 weeks
Title
TAC (mg/dL)
Description
Fasting serum total antioxidant capacity level
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetic patients with fasting blood sugar above 100 mg/dL or hemoglobin A1c above 6% in the last test Age between 20 to 65 years No use of insulin Exclusion Criteria: Changing usual medicine intake or making any changes in diet and lifestyle that could alter the effectiveness of the intervention Not using the fortified oil for three consecutive days or not using the fortified oil for more than ten days throughout the intervention period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tirang R. Neyestani, PhD
Phone
982122376471
Email
neytr@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bahareh Nikooyeh, PhD
Phone
982122376471
Email
nikooyeh11024@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tirang R. Neyestani, PhD
Organizational Affiliation
NationalNFTI, SBMU, Tehran, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
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
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tirang R. Neyestani, PhD
Phone
982122376471
Email
neytr@yahoo.com
First Name & Middle Initial & Last Name & Degree
Bahareh Nikooyeh, PhD
Phone
982122376471
Email
nikooyeh11024@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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