Evaluation of a Nutritional Technology for Vitamin D Absorption

NCT ID: NCT06266702

Last Updated: 2024-07-31

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-05-02

Brief Summary

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This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.

Detailed Description

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Conditions

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Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1A - High Vitamin D, Experimental Oil

High dose Vitamin D mixed with Experimental Oil

Group Type EXPERIMENTAL

Experimental Oil with Phospholipids

Intervention Type OTHER

Consumed on white bread

Group 1B - High Vitamin D, Control Oil

High Dose Vitamin D mixed with Control Oil

Group Type ACTIVE_COMPARATOR

Control Polyunsaturated Oil Blend

Intervention Type OTHER

Consumed on white bread

Group 2A - Low Vitamin D, Experimental Oil

Low dose Vitamin D mixed with Experimental Oil

Group Type EXPERIMENTAL

Experimental Oil with Phospholipids

Intervention Type OTHER

Consumed on white bread

Group 2B - Low Vitamin D, Control Oil

Low Dose Vitamin D mixed with Control Oil

Group Type ACTIVE_COMPARATOR

Control Polyunsaturated Oil Blend

Intervention Type OTHER

Consumed on white bread

Interventions

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Experimental Oil with Phospholipids

Consumed on white bread

Intervention Type OTHER

Control Polyunsaturated Oil Blend

Consumed on white bread

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult participants (18-55 years of age)
* Body mass index (BMI) \<30 kg/m2
* Males and nonpregnant, nonlactating females
* Free of gastrointestinal disorders that my impact nutrient absorption in the small intestine, endocrine, hepatic, renal, or bone diseases

Exclusion Criteria

* Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit.
* Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit.
* Travel to sunny location within 3 weeks prior to the Screening Visit.
* Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit.
* Has an allergy or intolerance to any ingredient in the study product.
* Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.
* Use of the following medications that may have interactions with vitamin D absorption or metabolism:

* Aluminum-containing phosphate binders
* Anticonvulsants
* Atorvastatin
* Calcipotriene
* Cholestyramine
* Cytochrome P-450 3A4 substrates
* Digoxin
* Diltiazem
* Orlistat
* Thiazide diuretics
* Corticosteroids
* Stimulant laxatives
* Verapamil
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Hertzler

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Walsh University

North Canton, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BL71

Identifier Type: -

Identifier Source: org_study_id

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