Innovative Food Structures to Enhance Nutrient Bioavailability

NCT ID: NCT04156074

Last Updated: 2023-03-06

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2021-12-31

Brief Summary

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This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups:

1. Vitamin D enriched (20ug) olive oil emulsion drink
2. Vitamin D enriched (20ug) coconut oil emulsion drink
3. Placebo emulsion drink
4. Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group.

Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention.

Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.

Detailed Description

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Conditions

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Vitamin D Deficiency Aging Well

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind

Study Groups

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Vitamin D enriched (20 mcg/day) olive oil emulsion drink

30 mL vitamin D enriched drink consumed daily for 4 weeks

Group Type EXPERIMENTAL

Vitamin D enriched (20 mcg/day) olive oil emulsion drink

Intervention Type DIETARY_SUPPLEMENT

Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

30 mL vitamin D enriched drink consumed daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

Intervention Type DIETARY_SUPPLEMENT

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily

Placebo coconut oil emulsion drink

30 mL placebo drink consumed daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo coconut oil emulsion drink

Intervention Type DIETARY_SUPPLEMENT

Placebo coconut oil emulsion drink 30 mL drink daily

Vitamin D supplement (20 mcg/day)

Vitamin D supplement consumed daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Vitamin D supplement (20 mcg/day)

Intervention Type DIETARY_SUPPLEMENT

Vitamin D supplement (20 mcg/day) Pill consumed daily

Interventions

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Vitamin D enriched (20 mcg/day) olive oil emulsion drink

Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily

Intervention Type DIETARY_SUPPLEMENT

Placebo coconut oil emulsion drink

Placebo coconut oil emulsion drink 30 mL drink daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin D supplement (20 mcg/day)

Vitamin D supplement (20 mcg/day) Pill consumed daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

• Healthy adults

Exclusion Criteria

* Pregnant/lactating
* Smokers
* Individuals who are not free-living
* An inability to read, write or understand English
* Following a strict diet for any reason, insulin dependent diabetes, coeliac etc.
* Disease that requires chronic therapeutic nutritional or medical treatment
* Those with conditions that may affect kidney function
* Those with osteoporosis
* Those taking supplemental vitamin D
* Those who have been on a sun holiday in the last 2 months
* Those with a milk protein allergy or lactose intolerance
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Agriculture Food and the Marine

UNKNOWN

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Aifric O'Sullivan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aifric O'Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

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University College Dublin

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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LS-19-56-McCourt-OSullivan

Identifier Type: -

Identifier Source: org_study_id

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