Nutrition, Healthy
Conditions
Brief summary
This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.
Interventions
OTHERExperimental Oil with Phospholipids
Consumed on white bread
OTHERControl Polyunsaturated Oil Blend
Consumed on white bread
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D Absorption | Time 0 to 24 Hours | Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D Absorption - Peak | Time 0 to 48 Hours | Change in Peak serum for vitamin D in experimental versus control oil |
| Vitamin D Absorption - AUC | Time 0 to 48 Hours | Change in AUC for vitamin D in experimental versus control oil |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Visit 1, Baseline Collection | As calculated from height in cm and weight in kg |
| Adverse Events | Study Day 1 to Study Day 7 up to 20 Days | Participant reported adverse events during study duration |
Countries
United States
Outcome results
None listed