Nutrition, HealthyNCT06266702
Evaluation of a Nutritional Technology for Vitamin D Absorption
A study testing Experimental Oil with Phospholipids in people with Nutrition, Healthy, run by Abbott Nutrition at 1 site in United States.
Trial summary
This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Experimental Oil with Phospholipids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Lipid-based Nutritional Technology for Enhancing Vitamin D Absorption in Humans
This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.
- Conditions
- Nutrition, Healthy
- Being tested
- Experimental Oil with Phospholipids, Control Polyunsaturated Oil Blend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Oil with PhospholipidsOther
Consumed on white bread
Control Polyunsaturated Oil BlendOther
Consumed on white bread
| Study group | Role | What they receive |
|---|---|---|
| Group 1A - High Vitamin D, Experimental Oil | Experimental | High dose Vitamin D mixed with Experimental Oil Receives: Other: Experimental Oil with Phospholipids |
| Group 1B - High Vitamin D, Control Oil | Active comparator | High Dose Vitamin D mixed with Control Oil Receives: Other: Control Polyunsaturated Oil Blend |
| Group 2A - Low Vitamin D, Experimental Oil | Experimental | Low dose Vitamin D mixed with Experimental Oil Receives: Other: Experimental Oil with Phospholipids |
| Group 2B - Low Vitamin D, Control Oil | Active comparator | Low Dose Vitamin D mixed with Control Oil Receives: Other: Control Polyunsaturated Oil Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D Absorption
Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil
Measured: Time 0 to 24 Hours
Secondary outcomes (2)
Vitamin D Absorption - Peak
Change in Peak serum for vitamin D in experimental versus control oil
Measured: Time 0 to 48 Hours
Vitamin D Absorption - AUC
Change in AUC for vitamin D in experimental versus control oil
Measured: Time 0 to 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Mar 2024
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Hertzler, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266702
- Sponsor's protocol ID
- BL71
- Status last verified
- Jul 2024
- First submitted
- 8 Jan 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lipid-based Nutritional Technology for Enhancing Vitamin D Absorption in Humans
- ClinicalTrials.gov ID
- NCT06266702
- Acronym / sponsor ID
- BL71
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A - High Vitamin D, Experimental Oil | Experimental | Other: Experimental Oil with PhospholipidsHigh dose Vitamin D mixed with Experimental Oil |
| Group 1B - High Vitamin D, Control Oil | Active comparator | Other: Control Polyunsaturated Oil BlendHigh Dose Vitamin D mixed with Control Oil |
| Group 2A - Low Vitamin D, Experimental Oil | Experimental | Other: Experimental Oil with PhospholipidsLow dose Vitamin D mixed with Experimental Oil |
| Group 2B - Low Vitamin D, Control Oil | Active comparator | Other: Control Polyunsaturated Oil BlendLow Dose Vitamin D mixed with Control Oil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Oil with PhospholipidsConsumed on white bread | Other | Group 1A - High Vitamin D, Experimental Oil, Group 2A - Low Vitamin D, Experimental Oil |
| Control Polyunsaturated Oil BlendConsumed on white bread | Other | Group 1B - High Vitamin D, Control Oil, Group 2B - Low Vitamin D, Control Oil |
Primary outcome
Vitamin D Absorption
Time frame: Time 0 to 24 Hours
Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil
2 secondary outcomes
Vitamin D Absorption - Peak
Time frame: Time 0 to 48 Hours
Vitamin D Absorption - AUC
Time frame: Time 0 to 48 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Hertzler study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Oil with Phospholipids in people with Nutrition, Healthy, run by Abbott Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D Absorption (time frame: Time 0 to 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.