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NCT04156074 Clinical Trial

Innovative Food Structures to Enhance Nutrient Bioavailability

Vitamin D Deficiency Clinical Trial

— NutriPlus  

Official title:
Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04156074
Other study ID # LS-19-56-McCourt-OSullivan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date December 31, 2021

Study information
Verified date March 2023
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vitamin D enriched (20 mcg/day) olive oil emulsion drink
Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily
• Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily
• Placebo coconut oil emulsion drink
Placebo coconut oil emulsion drink 30 mL drink daily
• Vitamin D supplement (20 mcg/day)
Vitamin D supplement (20 mcg/day) Pill consumed daily

Locations
Country Name City State
Ireland University College Dublin Dublin

Sponsors (2)
Lead Sponsor Collaborator
University College Dublin Department of Agriculture Food and the Marine

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin D status Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L) Baseline to 28 days
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