Innovative Food Structures to Enhance Nutrient Bioavailability (NutriPlus)
Primary Purpose
Vitamin D Deficiency, Aging Well
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Vitamin D enriched (20 mcg/day) olive oil emulsion drink
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
Placebo coconut oil emulsion drink
Vitamin D supplement (20 mcg/day)
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Bioavailability, Aging, Fortified foods, Vitamin D status, 25-hydroxyvitamin D
Eligibility Criteria
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
Sites / Locations
- University College Dublin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Vitamin D enriched (20 mcg/day) olive oil emulsion drink
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
Placebo coconut oil emulsion drink
Vitamin D supplement (20 mcg/day)
Arm Description
30 mL vitamin D enriched drink consumed daily for 4 weeks
30 mL vitamin D enriched drink consumed daily for 4 weeks
30 mL placebo drink consumed daily for 4 weeks
Vitamin D supplement consumed daily for 4 weeks
Outcomes
Primary Outcome Measures
Vitamin D status
Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)
Secondary Outcome Measures
Full Information
NCT ID
NCT04156074
First Posted
November 5, 2019
Last Updated
March 3, 2023
Sponsor
University College Dublin
Collaborators
Department of Agriculture Food and the Marine
1. Study Identification
Unique Protocol Identification Number
NCT04156074
Brief Title
Innovative Food Structures to Enhance Nutrient Bioavailability
Acronym
NutriPlus
Official Title
Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
Collaborators
Department of Agriculture Food and the Marine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
Vitamin D enriched (20ug) olive oil emulsion drink
Vitamin D enriched (20ug) coconut oil emulsion drink
Placebo emulsion drink
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Aging Well
Keywords
Vitamin D, Bioavailability, Aging, Fortified foods, Vitamin D status, 25-hydroxyvitamin D
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Randomized Controlled Trial
Masking
ParticipantInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D enriched (20 mcg/day) olive oil emulsion drink
Arm Type
Experimental
Arm Description
30 mL vitamin D enriched drink consumed daily for 4 weeks
Arm Title
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
Arm Type
Active Comparator
Arm Description
30 mL vitamin D enriched drink consumed daily for 4 weeks
Arm Title
Placebo coconut oil emulsion drink
Arm Type
Placebo Comparator
Arm Description
30 mL placebo drink consumed daily for 4 weeks
Arm Title
Vitamin D supplement (20 mcg/day)
Arm Type
Active Comparator
Arm Description
Vitamin D supplement consumed daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D enriched (20 mcg/day) olive oil emulsion drink
Intervention Description
Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
Intervention Description
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo coconut oil emulsion drink
Intervention Description
Placebo coconut oil emulsion drink 30 mL drink daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplement (20 mcg/day)
Intervention Description
Vitamin D supplement (20 mcg/day) Pill consumed daily
Primary Outcome Measure Information:
Title
Vitamin D status
Description
Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)
Time Frame
Baseline to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aifric O'Sullivan, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Dublin
City
Dublin
Country
Ireland
12. IPD Sharing Statement
Learn more about this trial
Innovative Food Structures to Enhance Nutrient Bioavailability
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