NCT05271045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 27, 2022

Last Update Submit

February 27, 2022

Conditions

Diabetes

Keywords

vitamin Avitamin Dγ-oryzanolfortified oil

Outcome Measures

Primary Outcomes (2)

  • serum glucose (mg/dL)

    Fasting serum glucose level

    8 weeks

  • serum HbA1c (mg/dL)

    Fasting serum HbA1c level

    8 weeks

Secondary Outcomes (21)

  • Weight (Kg)

    8 weeks

  • Body Mass Index (Kg/m2)

    8 weeks

  • Waist circumference (cm)

    8 weeks

  • 25-hydroxyvitamin D (nmol/L)

    8 weeks

  • serum triglyceride (mg/dL)

    8 weeks

  • +16 more secondary outcomes

Study Arms (3)

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)

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)

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)

Dietary Supplement: Placebo

Interventions

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

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

30 g fortified canola oil with vitamins A and D

fortified canola oil with vitamins A and D
PlaceboDIETARY_SUPPLEMENT

30 g fortified sunflower oil with vitamins A and D

fortified sunflower oil with vitamins A and D

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37971692DERIVED

  • 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.

    PMID: 37817285DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tirang R. Neyestani, PhD

    NationalNFTI, SBMU, Tehran, Iran

    STUDY CHAIR

Central Study Contacts

Tirang R. Neyestani, PhD

CONTACT

982122376471neytr@yahoo.com

Bahareh Nikooyeh, PhD

CONTACT

982122376471nikooyeh11024@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 8, 2022

Study Start

December 1, 2021

Primary Completion

April 1, 2022

Study Completion

July 1, 2022

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations

IR(1)