Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes
NCT ID: NCT05271045
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2021-12-01
2022-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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)
fortified canola oil with vitamins A and D and γ-oryzanol
30 g fortified canola oil with vitamins A and D and γ-oryzanol
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)
Active comparator
30 g fortified canola oil with vitamins A and D
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)
Placebo
30 g fortified sunflower oil with vitamins A and D
Interventions
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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
30 g fortified canola oil with vitamins A and D
Placebo
30 g fortified sunflower oil with vitamins A and D
Eligibility Criteria
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Inclusion Criteria
2. Age between 20 to 65 years
3. No use of insulin
Exclusion Criteria
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
20 Years
65 Years
ALL
No
Sponsors
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National Nutrition and Food Technology Institute
OTHER
Responsible Party
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Tirang R. Neyestani, Ph.D.
Prof.
Principal Investigators
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Tirang R. Neyestani, PhD
Role: STUDY_CHAIR
NationalNFTI, SBMU, Tehran, Iran
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Nikooyeh 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.
Other Identifiers
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25
Identifier Type: -
Identifier Source: org_study_id
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