Evaluation of a Nutritional Technology for Vitamin D Absorption

NCT06266702 | Completed

• 1 other identifier: BL71
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (1)

• Vitamin D Absorption

  Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil

  Time 0 to 24 Hours

Secondary Outcomes (2)

• Vitamin D Absorption - Peak

  Time 0 to 48 Hours

• Vitamin D Absorption - AUC

  Time 0 to 48 Hours

Other Outcomes (2)

• Body Mass Index

  Visit 1, Baseline Collection

• Adverse Events

  Study Day 1 to Study Day 7 up to 20 Days

Study Arms (4)

Group 1A - High Vitamin D, Experimental Oil

EXPERIMENTAL

High dose Vitamin D mixed with Experimental Oil

Other: Experimental Oil with Phospholipids

Group 1B - High Vitamin D, Control Oil

ACTIVE COMPARATOR

High Dose Vitamin D mixed with Control Oil

Other: Control Polyunsaturated Oil Blend

Group 2A - Low Vitamin D, Experimental Oil

EXPERIMENTAL

Low dose Vitamin D mixed with Experimental Oil

Other: Experimental Oil with Phospholipids

Group 2B - Low Vitamin D, Control Oil

ACTIVE COMPARATOR

Low Dose Vitamin D mixed with Control Oil

Other: Control Polyunsaturated Oil Blend

Interventions

Experimental Oil with Phospholipids OTHER

Consumed on white bread

Group 1A - High Vitamin D, Experimental Oil; Group 2A - Low Vitamin D, Experimental Oil

Control Polyunsaturated Oil Blend OTHER

Consumed on white bread

Group 1B - High Vitamin D, Control Oil; Group 2B - Low Vitamin D, Control Oil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Walsh University

North Canton, Ohio, 44720, United States

Location

MeSH Terms

Interventions

Phospholipids

Intervention Hierarchy (Ancestors)

Membrane Lipids; Lipids

Study Officials

• Steve Hertzler

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 20, 2024
• Study Start: March 15, 2024
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)