DiabetesNCT05271045
Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes
A study testing fortified canola oil with vitamins A and D and γ-oryzanol and Active comparator in people with Diabetes, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- fortified canola oil with vitamins A and D and γ-oryzanol and Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- 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
Tehran
Tirang R. Neyestani, PhD, 982122376471, neytr@yahoo.com
Bahareh Nikooyeh, PhD, 982122376471, nikooyeh11024@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- fortified canola oil with vitamins A and D and γ-oryzanol, Active comparator, Placebo
- Keywords
- vitamin A, vitamin D, γ-oryzanol, fortified oil
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified canola oil with vitamins A and D and γ-oryzanolDietary supplement
30 g fortified canola oil with vitamins A and D and γ-oryzanol
Active comparatorDietary supplement
30 g fortified canola oil with vitamins A and D
PlaceboDietary supplement
30 g fortified sunflower oil with vitamins A and D
| Study group | Role | What they receive |
|---|---|---|
| fortified canola oil with vitamins A and D and γ-oryzanol | Experimental | daily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g \& 2130 ppm γ-oryzanol/30g) Receives: Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanol |
| fortified canola oil with vitamins A and D | Active comparator | daily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g) Receives: Dietary Supplement: Active comparator |
| fortified sunflower oil with vitamins A and D | Placebo comparator | daily intake of fortified sunflower oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum glucose (mg/dL)
Fasting serum glucose level
Measured: 8 weeks
serum HbA1c (mg/dL)
Fasting serum HbA1c level
Measured: 8 weeks
Secondary outcomes (21)
Weight (Kg)
Subject's weight wearing light clothing
Measured: 8 weeks
Body Mass Index (Kg/m2)
weight (kg) divided by the square of height (m)
Measured: 8 weeks
Waist circumference (cm)
the measurement at the midpoint between the lowest rib and the iliac crest
Measured: 8 weeks
25-hydroxyvitamin D (nmol/L)
Fasting serum 25-hydroxyvitamin D level
Measured: 8 weeks
serum triglyceride (mg/dL)
Fasting serum triglyceride level
Measured: 8 weeks
serum total cholesterol (mg/dL)
Fasting serum total cholesterol level
Measured: 8 weeks
serum LDL (mg/dL)
Fasting serum low density lipoprotein level
Measured: 8 weeks
serum HDL (mg/dL)
Fasting serum high density lipoprotein level
Measured: 8 weeks
serum insulin (pg/mL)
Fasting serum insulin level
Measured: 8 weeks
serum BUN (mg/dL)
Fasting serum BUN level
Measured: 8 weeks
serum creatinine (mg/dL)
Fasting serum creatinine level
Measured: 8 weeks
serum leptin (pg/mL)
Fasting serum leptin level
Measured: 8 weeks
serum grelin (pg/mL)
Fasting serum grelin level
Measured: 8 weeks
serum hsCRP (pg/mL)
Fasting serum high sensitivity c-reactive protein level
Measured: 8 weeks
serum IL-6 (pg/mL)
Fasting serum Interleukin-6 level
Measured: 8 weeks
serum IL-1β (pg/mL)
Fasting serum Interleukin-1β level
Measured: 8 weeks
serum INF-γ (pg/mL)
Fasting serum INF-γ level
Measured: 8 weeks
salivary sIg-A (pg/mL)
Fasting Salivary Secretory Immunoglobulin A
Measured: 8 weeks
ox-LDL (mg/dL)
Fasting oxidized low density lipoprotein level
Measured: 8 weeks
MDA (mg/dL)
Fasting serum malondialdehyde level
Measured: 8 weeks
TAC (mg/dL)
Fasting serum total antioxidant capacity level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Dec 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, PhD, Study chair, NationalNFTI, SBMU, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271045
- Sponsor's protocol ID
- 25
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nikooyeh B, Zargaraan A, Ebrahimof S, Kalayi A, Zahedirad M, Yazdani H, Rismanchi M, Karami T, Khazraei M, Jafarpour A, Neyestani TR. Added gamma-oryzanol boosted anti-inflammatory effects of canola oil in adult subjects with type 2 diabetes: a randomized controlled clinical trial. Eur J Nutr. 2024 Mar;63(2):425-433. doi: 10.1007/s00394-023-03275-w. Epub 2023 Nov 16.
PubMed 37971692Nikooyeh B, Zargaraan A, Ebrahimof S, Kalayi A, Zahedirad M, Yazdani H, Rismanchi M, Karami T, Khazraei M, Jafarpour A, Neyestani TR. Daily consumption of gamma-oryzanol-fortified canola oil, compared with unfortified canola and sunflower oils, resulted in a better improvement of certain cardiometabolic biomarkers of adult subjects with type 2 diabetes: a randomized controlled clinical trial. Eur J Med Res. 2023 Oct 10;28(1):416. doi: 10.1186/s40001-023-01409-8.
PubMed 37817285
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05271045
- Acronym / sponsor ID
- 25
- Conditions
- Diabetes
- Keywords
- vitamin A, vitamin D, γ-oryzanol, fortified oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fortified canola oil with vitamins A and D and γ-oryzanol | Experimental | Dietary Supplement: fortified canola oil with vitamins A and D and γ-oryzanoldaily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g \& 2130 ppm γ-oryzanol/30g) |
| fortified canola oil with vitamins A and D | Active comparator | Dietary Supplement: Active comparatordaily intake of fortified canola oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g) |
| fortified sunflower oil with vitamins A and D | Placebo comparator | Dietary Supplement: Placebodaily intake of fortified sunflower oil (385 IU vitamin D/ 30g \& 154 IU vitamin A/30 g) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortified canola oil with vitamins A and D and γ-oryzanol30 g fortified canola oil with vitamins A and D and γ-oryzanol | Dietary supplement | fortified canola oil with vitamins A and D and γ-oryzanol |
| Active comparator30 g fortified canola oil with vitamins A and D | Dietary supplement | fortified canola oil with vitamins A and D |
| Placebo30 g fortified sunflower oil with vitamins A and D | Dietary supplement | fortified sunflower oil with vitamins A and D |
Primary outcome
serum glucose (mg/dL)
Time frame: 8 weeks
Fasting serum glucose level
serum HbA1c (mg/dL)
Time frame: 8 weeks
Fasting serum HbA1c level
21 secondary outcomes
Weight (Kg)
Time frame: 8 weeks
Body Mass Index (Kg/m2)
Time frame: 8 weeks
Waist circumference (cm)
Time frame: 8 weeks
25-hydroxyvitamin D (nmol/L)
Time frame: 8 weeks
serum triglyceride (mg/dL)
Time frame: 8 weeks
serum total cholesterol (mg/dL)
Time frame: 8 weeks
serum LDL (mg/dL)
Time frame: 8 weeks
serum HDL (mg/dL)
Time frame: 8 weeks
serum insulin (pg/mL)
Time frame: 8 weeks
serum BUN (mg/dL)
Time frame: 8 weeks
serum creatinine (mg/dL)
Time frame: 8 weeks
serum leptin (pg/mL)
Time frame: 8 weeks
serum grelin (pg/mL)
Time frame: 8 weeks
serum hsCRP (pg/mL)
Time frame: 8 weeks
serum IL-6 (pg/mL)
Time frame: 8 weeks
serum IL-1β (pg/mL)
Time frame: 8 weeks
serum INF-γ (pg/mL)
Time frame: 8 weeks
salivary sIg-A (pg/mL)
Time frame: 8 weeks
ox-LDL (mg/dL)
Time frame: 8 weeks
MDA (mg/dL)
Time frame: 8 weeks
TAC (mg/dL)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 37971692Nikooyeh B, Zargaraan A, Ebrahimof S, Kalayi A, Zahedirad M, Yazdani H, Rismanchi M, Karami T, Khazraei M, Jafarpour A, Neyestani TR. Added gamma-oryzanol boosted anti-inflammatory effects of canola oil in adult subjects with type 2 diabetes: a randomized controlled clinical trial. Eur J Nutr. 2024 Mar;63(2):425-433. doi: 10.1007/s00394-023-03275-w. Epub 2023 Nov 16.
- Derived from this study: PubMed 37817285Nikooyeh B, Zargaraan A, Ebrahimof S, Kalayi A, Zahedirad M, Yazdani H, Rismanchi M, Karami T, Khazraei M, Jafarpour A, Neyestani TR. Daily consumption of gamma-oryzanol-fortified canola oil, compared with unfortified canola and sunflower oils, resulted in a better improvement of certain cardiometabolic biomarkers of adult subjects with type 2 diabetes: a randomized controlled clinical trial. Eur J Med Res. 2023 Oct 10;28(1):416. doi: 10.1186/s40001-023-01409-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirang R. Neyestani, PhD study chair
NationalNFTI, SBMU, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fortified canola oil with vitamins A and D and γ-oryzanol and Active comparator in people with Diabetes, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tirang R. Neyestani, PhD (982122376471, neytr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum glucose (mg/dL) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.