Evaluation of a Nutritional Technology for Vitamin D Absorption

Not Applicable

Completed

• Conditions: Nutrition, Healthy
• Interventions: Other: Experimental Oil with Phospholipids; Other: Control Polyunsaturated Oil Blend

• Registration Number: NCT06266702
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-20
• Study Start: 2024-03-15
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1A - High Vitamin D, Experimental Oil	Experimental Oil with Phospholipids	High dose Vitamin D mixed with Experimental Oil
Group 2A - Low Vitamin D, Experimental Oil	Experimental Oil with Phospholipids	Low dose Vitamin D mixed with Experimental Oil
Group 1B - High Vitamin D, Control Oil	Control Polyunsaturated Oil Blend	High Dose Vitamin D mixed with Control Oil
Group 2B - Low Vitamin D, Control Oil	Control Polyunsaturated Oil Blend	Low Dose Vitamin D mixed with Control Oil

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Walsh University; 🇺🇸 North Canton, Ohio, United States