Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-07-01

Brief Summary

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The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.

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Detailed Description

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Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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fortified oil

daily intake of fortified sunflower oil (700IU vitamin D/ 35g)

Group Type EXPERIMENTAL

fortified oil

Intervention Type DIETARY_SUPPLEMENT

35 g fortified sunflower oil

control

daily intake of plain oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

plain oil

Interventions

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fortified oil

35 g fortified sunflower oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

plain oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 20 to 60 years
* healthy subjects
* no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion Criteria

\- receiving vitamin D or omega-3 supplement during the study

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Tirang R. Neyestani, Ph.D.

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tirang R. Neyestani, PhD

Role: STUDY_CHAIR

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